June 21, 2008FDA inspectors head to Fla., Mexico tomato farms - MSNBC FDA inspectors head to Fla., Mexico tomato farms - MSNBC
NEW YORK - Food and Drug Administration inspectors are heading for farms in Florida and Mexico, as new clues emerge to the possible source of salmonella-tainted tomatoes that have now sickened 552 people. The FDA wouldn’t say where in Florida and Source: www.msnbc.msn.com GSK Update on FDA Review of Promacta(R) (Eltrombopag) - Biloxi Sun Herald GlaxoSmithKline (NYSE: GSK) today announced that the United States Food and Drug Administration has extended the priority review period for PROMACTA(R) (eltrombopag) for the short-term treatment of previously treated patients with chronic idiopathic Source: www.sunherald.com Group sues FDA to get risky painkiller off market - Houston Chronicle WASHINGTON — A prescription painkiller sold under such names as Darvon and Darvocet is too risky to stay on the market, a consumer advocacy group argued today in suing the Food and Drug Administration. Public Citizen petitioned the FDA two years Source: www.chron.com Merck cholesterol drug likely delayed until 2013 - Boston Globe WHITEHOUSE STATION, N.J.— Merck & Co. said Friday it will probably be 2013 before regulators reconsider approval of the cholesterol drug the company was counting on to rejuvenate sales growth. The Food and Drug Administration rejected the drug in Source: www.boston.com U.S. FDA seeks India post for food, drug checks - Reuters India U.S. FDA seeks India post for food, drug checks - Reuters India
WASHINGTON (Reuters) - The U.S. Food and Drug Administration hopes to establish operations in India by year's end to better police the growing volume of food, medicines, medical devices and animal feed exported to the United States, a top official Source: in.reuters.com FDA sued for failure to act on risky painkiller - Katu.com WASHINGTON (AP) - A prescription painkiller sold under such names as Darvon and Darvocet is too risky to stay on the market, a consumer advocacy group argued Thursday in suing the Food and Drug Administration. Public Citizen petitioned the FDA two Source: www.katu.com FDA Approves GlaxoSmithKline's AVODART(R) in Combination with - PR Newswire PHILADELPHIA, June 19 /PRNewswire-FirstCall/ -- GlaxoSmithKline NYSE: GSK today announced that the U.S. Food and Drug Administration (FDA) has approved AVODART (dutasteride) in combination with tamsulosin for the treatment of symptomatic enlarged Source: sev.prnewswire.com Mexico applauds US decision to clear some of its tomatoes in - International Herald Tribune MEXICO CITY : The U.S. has cleared tomatoes in 28 of 31 Mexican states from suspicion in a recent salmonella outbreak, a move that drew praise from Mexican officials Saturday. The U.S. Food and Drug Administration now appears to be narrowing its Source: www.iht.com Glenmark gets FDA nod to market anti-hypertension drug Trandolapril - CNBC LONDON (Thomson Financial) - India's Glenmark Pharmaceuticals Ltd. said its unit Glenmark Generics Ltd. has got Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration for marketing and distribution of Trandolapril Source: www.cnbc.com J&J skin drug could face slow uptake, analysts say - CNBC While a Food and Drug Administration advisory panel Tuesday unanimously recommended approval of a Johnson & Johnson drug to treat a severe skin disease, some analysts said the panel's suggested restrictions on the drug could limit potential sales Source: www.cnbc.com NY FARMERS JUICED - New York Post The attack of the killer tomatoes isn't rotten news for New York farmers. The latest food scare that squashed $40 million from the industry in Florida and destroyed Mexican imports is yielding a bumper crop for early-season growers in the state - one Source: www.nypost.com RPT-INTERVIEW-US FDA seeks India post for food, drug checks - Reuters India WASHINGTON, June 19 (Reuters) - The U.S. Food and Drug Administration hopes to establish operations in India by year's end to better police the growing volume of food, medicines, medical devices and animal feed exported to the United States, a top Source: in.reuters.com Is Merck Flying Blind? - Forbes Is Merck Flying Blind? - Forbes
The U.S. Food and Drug Administration rejected Merck 's cholesterol combination pill in April. Merck now says the FDA has suggested it wait five years before resubmitting the drug. The big question raised is not just when Cordaptive will get approved Source: www.forbes.com Mexico applauds US decision to clear some of its tomatoes in - International Herald Tribune MEXICO CITY : The U.S. has cleared tomatoes in 28 of 31 Mexican states from suspicion in a recent salmonella outbreak, a move that drew praise from Mexican officials Saturday. The U.S. Food and Drug Administration now appears to be narrowing its Source: www.iht.com U.S. food inspectors head to Florida, Mexico in salmonella probe - Canada East WASHINGTON - U.S. Food and Drug Administration inspectors are heading for farms in Florida and Mexico, as new clues emerge to the possible source of salmonella-tainted tomatoes that have now sickened 552 people. The FDA wouldn't say where in Florida Source: www.canadaeast.com Biovail stock falls after analyst cuts rating - CNBC NEW YORK - Shares of drug developer Biovail Corp. sank Friday after a CIBC analyst said generic drug launches will likely keep pressuring the company's revenue and restructuring efforts will be costly. Biovail is shifting its focus to central nervous Source: www.cnbc.com FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs
The U.S. Food and Drug Administration today exercised its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to require manufacturers of "conventional" antipsychotic drugs to make safety-related changes to prescribing information, or labeling, to warn about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia. FDA Announces Limited Return of Heartworm Drug to U.S. Market ProHeart 6 Sustained Release Injectable for Dogs, manufactured by Fort Dodge Animal Health, is an approved injectable sustained-release heartworm prevention product for dogs. FDA is concurring with its limited return, to the U.S. veterinary market under a risk minimization and restricted distribution program designed to manage the re-introduction of ProHeart 6 to provide for safe, appropriate use of the product while minimizing risk to dogs. FDA's Chief Scientist Asks Science Board Subcommittee to Review Research on Bisphenol-A Frank M. Torti, M.D., M.P.H., the FDA's principal deputy commissioner and chief scientist, this week asked Science Board Chairwoman Barbara J. McNeil, M.D., Ph.D., head of Health Care Policy at Harvard Medical School, to establish a subcommittee to assess BPA, a substance used in some plastic baby bottles, food containers, and water bottles. Heartworm Prevention in Your Pet A variety of FDA-approved heartworm prevention products are available to protect your pet from this potentially deadly infection, including ProHeart 6 injection for dogs under a restricted distribution program. Warning for Regranex—Cream for Leg and Foot Ulcers A boxed warning has been added to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer death in patients who use three or more tubes of the product. FDA Requests Seizure of Animal Food Products at PETCO Distribution Center FDA Requests Seizure of Animal Food Products at PETCO Distribution Center
At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago. Sweetwater Valley Farm, Inc. Recalls Tennessee Aged Black Pepper Cheese (May 15) Sweetwater Valley Farm, Inc. is recalling Tennessee Aged Black Pepper Cheese because it has the potential to be contaminated with Listeria monocytogenes. The cheese, Lot Number 616-361 was distributed in 5, 7, and 10 ounce bars through our retail store in Philadelphia, TN and a Winery in Portland, TN. FDA Advises Patients to Switch to HFA-Propelled Albuterol Inhalers Now CFC-propelled albuterol inhalers are being phased out because they are harmful to the environment by contributing to depletion of the ozone layer above the Earth's surface. Recalls and Safety Alerts: Inflammatory Masses with Synchromed and IsoMed Implantable Infusion Pumps On January 16, 2008, Medtronic notified healthcare professionals about an increased rate of inflammatory masses in patients receiving intrathecal drugs through the company's Synchromed EL, Synchromed II and IsoMed implantable infusion pump systems. ... FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these raw, red tomatoes. FDA Takes Action against Seafood Processing Company, Executives The U.S. Food and Drug Administration today filed a complaint for permanent injunction against seafood processor Captain's Select Seafood, Inc., Minneapolis, Minn., and two of its top officers for violating the Federal Food, Drug and Cosmetic Act. FDA's Chief Scientist Asks Science Board Subcommittee to Review Research on Bisphenol-A Frank M. Torti, M.D., M.P.H., the FDA's principal deputy commissioner and chief scientist, this week asked Science Board Chairwoman Barbara J. McNeil, M.D., Ph.D., head of Health Care Policy at Harvard Medical School, to establish a subcommittee to assess BPA, a substance used in some plastic baby bottles, food containers, and water bottles. FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs The U.S. Food and Drug Administration today exercised its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to require manufacturers of "conventional" antipsychotic drugs to make safety-related changes to prescribing information, or labeling, to warn about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia. Abbott Announces Voluntary Worldwide Recall of Two Lots of Calcilo XD Low-Calcium/Vitamin D-Free Infant Formula with Iron Powder in 14.1-Ounce (400g) Cans (May 30) Abbott Announces Voluntary Worldwide Recall of Two Lots of Calcilo XD Low-Calcium/Vitamin D-Free Infant Formula with Iron Powder in 14.1-Ounce (400g) Cans (May 30)
Abbott announced a voluntary worldwide recall of two lots of Calcilo XD Low-Calcium/Vitamin D-Free Infant Formula with Iron powder in 14.1-ounce cans (400g). Only 14.1-ounce (400g) cans are involved in this action. Calcilo XD is a low-calcium and vitamin D-free infant formula that is specifically designed for the nutrition support of infants and children with hypercalcemia (high calcium in blood). It is only available by special order. ETHEX Corporation Voluntarily Recalls Specific Lots of 30 mg. and 60 mg. Morphine Sulfate Extended Release Tablets Due to the Potential for Oversized Tablets (June 13) ETHEX Corporation announced today that it has voluntarily recalled specific additional lots of morphine sulfate 60 mg extended release tablets, and specific lots of morphine sulfate 30 mg extended release tablets, as a precaution, due to the possible presence of oversized tablets. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate. The recalled lots were distributed by ETHEX Corporation under an "ETHEX" label between June 2006 and May 2008. FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes
The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these raw, red tomatoes. Abbott Announces Voluntary Worldwide Recall of Two Lots of Calcilo XD Low-Calcium/Vitamin D-Free Infant Formula with Iron Powder in 14.1-Ounce (400g) Cans (May 30) Abbott announced a voluntary worldwide recall of two lots of Calcilo XD Low-Calcium/Vitamin D-Free Infant Formula with Iron powder in 14.1-ounce cans (400g). Only 14.1-ounce (400g) cans are involved in this action. Calcilo XD is a low-calcium and vitamin D-free infant formula that is specifically designed for the nutrition support of infants and children with hypercalcemia (high calcium in blood). It is only available by special order. Fresca Italia, Inc., Recalls Burrata Because of Possible Health Risk (May 30) Fresca Italia of Brisbane, CA is recalling Burrata because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as fever, headache, stiffness, nausea, abdominal, or diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women. Kraft Foods Issues Allergy Alert On Undeclared Tree Nuts In Post LiveActive Mixed Berry Crunch Cereal (June 5) Kraft Foods is recalling 12,553 cases of Post LiveActive Mixed Berry Crunch Cereal with the “Best When Used By” date of 17DEC2008 because a small number of boxes may contain tree nuts (almonds, pecans and/or walnuts), and no nut ingredients are declared on the label. The Post LiveActive Mixed Berry Crunch Cereal has a UPC code of 00430000238900 and comes in a 13-oz retail carton. People who have an allergy or severe sensitivity to tree nuts run the risk of serious or life-threatening allergic reaction if they consume these products. Important Information about Albuterol Metered Dose Inhalers (MDIs) After December 31, 2008, albuterol CFC MDIs are prohibited from being sold or distributed in the United States. Therefore, patients are encouraged to talk with their health care providers now to begin the transition to an HFA propelled albuterol MDI. After the transition is complete, it is anticipated that supplies of albuterol HFA and levalbuterol HFA MDIs will continue to meet the total market demand. FDA is working closely with manufacturers to ensure that there is adequate supply of the HFA propelled albuterol and levalbuterol MDI products available. (more information) Leiner Health Products Issues Allergy Alert on Undeclared Allergens in Liquimax Multivitamin (June 6) Leiner Health Products Inc. announced that it is recalling its 32 ounce plastic bottles of Liquimax Complete Nutrition Multivitamin Formula, labeled with UPC Code 7497052290, 7497023607, or 7497023696 because the product may contain undeclared fish (not shellfish), tree nuts (almonds, pecans and/or walnuts), and wheat. People who have allergies to fish, tree nuts and/or wheat run the risk of serious or life-threatening allergic reaction if they consume these products. Analysts: Discovery Labs sell-off overdone - Forbes Analysts: Discovery Labs sell-off overdone - Forbes
Analysts said Thursday investors are overreacting to news that Discovery Laboratories Inc. will delay its response to the Food and Drug Administration's request for information about the company's Surfaxin drug by three months. Last month, the FDA Source: www.forbes.com FDA Gets Break In Salmonella Case - KNx 1070 Washington, D.C. (AP) -- There may be a break in the salmonella case: Food and Drug Administration inspectors headed for farms in Florida and Mexico on Friday, as new clues emerge to the possible source of salmonella-tainted tomatoes that have now Source: www.knx1070.com June 20, 2008FDA inspectors head to Fla., Mexico tomato farms - MSNBC FDA inspectors head to Fla., Mexico tomato farms - MSNBC
NEW YORK - Food and Drug Administration inspectors are heading for farms in Florida and Mexico, as new clues emerge to the possible source of salmonella-tainted tomatoes that have now sickened 552 people. The FDA wouldn’t say where in Florida and Source: www.msnbc.msn.com Group Sues FDA Over Painkiller - Time Group Sues FDA Over Painkiller - Time
(WASHINGTON) — A prescription painkiller sold under such names as Darvon and Darvocet is too risky to stay on the market, a consumer advocacy group argued Thursday in suing the Food and Drug Administration. Public Citizen petitioned the FDA two Source: www.time.com FDA inspectors to Fla., Mexico in salmonella probe - Los Angeles Times WASHINGTON -- There may be a break in the salmonella case: Food and Drug Administration inspectors headed for farms in Florida and Mexico on Friday, as new clues emerge to the possible source of salmonella-tainted tomatoes that have now sickened 552 Source: www.latimes.com Biovail stock falls after analyst cuts rating - CNBC NEW YORK - Shares of drug developer Biovail Corp. sank Friday after a CIBC analyst said generic drug launches will likely keep pressuring the company's revenue and restructuring efforts will be costly. Biovail is shifting its focus to central nervous Source: www.cnbc.com FDA widens tomato inquiry - Miami Herald The Food and Drug Administration said Friday it is heading to farms in Florida and Mexico, searching for the potential source of salmonella-tainted tomatoes that have now sickened 552 people. Source: www.miamiherald.com Drug treatment facility halted in Perry Twp. - Herald-Standard A Fayette County judge has granted an injunction to close a drug treatment facility in Perry Township. On Thursday, Judge Gerald R. Solomon granted the injunction prohibiting Louis Waller and LLS Realty LLC "from operating a substance abuse treatment Source: www.heraldstandard.com Salmonella outbreak linked to Florida, Mexico farms - Los Angeles Times Several farms in Florida and Mexico appear to have produced at least some of the tomatoes implicated in what is shaping up to be the country's largest tomato-borne salmonella outbreak, federal health officials said Friday. But the lengthy search for Source: www.latimes.com Is Merck Flying Blind? - Forbes The U.S. Food and Drug Administration rejected Merck 's cholesterol combination pill in April. Merck now says the FDA has suggested it wait five years before resubmitting the drug. The big question raised is not just when Cordaptive will get approved Source: www.forbes.com FDA inspectors head to Fla., Mexico tomato farms - MSNBC NEW YORK - Food and Drug Administration inspectors are heading for farms in Florida and Mexico, as new clues emerge to the possible source of salmonella-tainted tomatoes that have now sickened 552 people. The FDA wouldn’t say where in Florida and Source: www.msnbc.msn.com U.S. food inspectors head to Florida, Mexico in salmonella probe - Canada East WASHINGTON - U.S. Food and Drug Administration inspectors are heading for farms in Florida and Mexico, as new clues emerge to the possible source of salmonella-tainted tomatoes that have now sickened 552 people. The FDA wouldn't say where in Florida Source: www.canadaeast.com FDA narrows scope of outbreak investigation - Thepacker.com FDA narrows scope of outbreak investigation - Thepacker.com
A Primuslabs.com microbiologist adds salmonella enrichment to a tomato sample received in the company's corporate Santa Maria, Calif., laboratory. Primuslabs.com also has full pathogen labs in Salinas, Calif., and Yuma, Ariz. Courtesy Primuslabs.com Source: thepacker.com FDA complaints: How to make voice heard - Miami Herald The Miami Herald is pleased to provide this opportunity to share information, experiences and observations about what's in the news. Some of the comments may be reprinted elsewhere in the site or in the newspaper. We encourage lively, open debate on Source: www.miamiherald.com Contaminated Nipple Cream Contaminated Nipple Cream
FDA is warning nursing mothers not to buy or use Mommy's Bliss Nipple Cream because it contains potentially harmful ingredients. Warning on Certain Types of Raw Red Tomatoes FDA is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes. Tainted tomato cases reach 552 - MSNBC Tainted tomato cases reach 552 - MSNBC
NEW YORK - Food and Drug Administration inspectors are heading for farms in Florida and Mexico, as new clues emerge to the possible source of salmonella-tainted tomatoes that have now sickened 552 people. The FDA wouldn’t say where in Florida and Source: www.msnbc.msn.com Ligand Partner GlaxoSmithKline Receives FDA Extended Priority Review - MSN MoneyCentral Ligand Pharmaceuticals Incorporated LGND announced today that the U.S. Food and Drug Administration has extended the priority review period for GlaxoSmithKline ’ s (GSK) New Drug Application (NDA) for PROMACTA ® (eltrombopag) for the short-term Source: news.moneycentral.msn.com FDA Requests Seizure of Animal Food Products at PETCO Distribution - WebWire Today, at the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant Source: www.webwire.com Ligand says FDA extends blood-clot drug review - CNBC NEW YORK - Drug developer Ligand Pharmaceuticals Inc. said after the bell Friday the Food and Drug Administration will take an additional three months to review its experimental blood-clotting drug Promacta. The drug, which Ligand developed with Source: www.cnbc.com FDA says deaths with heart imaging drugs continue - Boston Globe WASHINGTON— Despite previous warnings to physicians, drugs used to improve medical images of the heart continue to be linked to serious side effects and some deaths, regulators said Friday. The Food and Drug Administration said that since October Source: www.boston.com Warning for Regranex—Cream for Leg and Foot Ulcers Warning for Regranex—Cream for Leg and Foot Ulcers
A boxed warning has been added to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer death in patients who use three or more tubes of the product. Drug to be Discontinued: Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension) Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension), Dear Healthcare Professional Letter available for more information. Sentinel System to Monitor Medical Product Safety FDA's new Sentinel Initiative aims to establish a national electronic system for tracking medical product performance. Important Information about Albuterol Metered Dose Inhalers (MDIs) After December 31, 2008, albuterol CFC MDIs are prohibited from being sold or distributed in the United States. Therefore, patients are encouraged to talk with their health care providers now to begin the transition to an HFA propelled albuterol MDI. After the transition is complete, it is anticipated that supplies of albuterol HFA and levalbuterol HFA MDIs will continue to meet the total market demand. FDA is working closely with manufacturers to ensure that there is adequate supply of the HFA propelled albuterol and levalbuterol MDI products available. (more information) FDA 101: How to Use the Consumer Complaint System and MedWatch When you have a problem with a food, drug, or other FDA-regulated product, FDA wants to hear from you. Here's how to report problems using two of FDA's main reporting systems. Drug to be Discontinued: Intal Nebulizer Solution (cromolyn sodium inhalation solution, USP) Intal Nebulizer Solution (cromolyn sodium inhalation solution, USP. Dear Healthcare Professional Letter is available for more information. Pregnant Women to Benefit from Better Information A proposed rule will give women and their health care professionals better information concerning the effects of medications taken during pregnancy or while breastfeeding. Analysts see higher drug sales for Cephalon - Forbes Analysts see higher drug sales for Cephalon - Forbes
Sales of Cephalon Inc.'s muscle relaxant Amrix and cancer treatment Treanda will likely continue to drive revenue for the Frazer, Pa.-based drug developer, several analysts said Friday. Cephalon has somewhat shifted its focus to Amrix and Treanda Source: www.forbes.com Merck cholesterol drug likely delayed until 2013 - Forbes Merck & Co. said Friday it will probably be 2013 before regulators reconsider approval of the cholesterol drug the company was counting on to rejuvenate sales growth. The Food and Drug Administration rejected the drug in April, saying it needed more Source: www.forbes.com FDA says deaths with heart imaging drugs continue - CNBC WASHINGTON - Despite previous warnings to physicians, drugs used to improve medical images of the heart continue to cause fatal side effects, regulators said Friday. The Food and Drug Administration said that since October it has received four Source: www.cnbc.com Concerns remain over heart imaging agents: FDA - Reuters WASHINGTON (Reuters) - U.S. health regulators remain concerned about the safety of contrast agents used to enhance echocardiogram heart imaging tests, according to Food and Drug Administration documents released on Friday. The products -- which Source: www.reuters.com FDA sued for failure to act on risky painkiller - Los Angeles Times WASHINGTON -- A prescription painkiller sold under such names as Darvon and Darvocet is too risky to stay on the market, a consumer advocacy group argued Thursday in suing the Food and Drug Administration. Public Citizen petitioned the FDA two years Source: www.latimes.com Concerns linger over imaging agents: FDA - Reuters WASHINGTON (Reuters) - U.S. health regulators are still concerned about the safety of imaging contrast agents used for ultrasound and echocardiograph tests, according to Food and Drug Administration documents released on Friday. The contrast products Source: www.reuters.com House Vote for More Food Safety Money Praised - Center for Science in Public Interest The Food and Drug Administration desperately needs the $150 million in new money approved by the House of Representatives last night, particularly the $67 million designated for the Centers for Food Safety and Applied Nutrition. It's good news for Source: www.cspinet.org UPDATE: Long Delay Seen For Merck's Cholesterol Drug - CNN Money Merck & Co. (MRK) was dealt another setback in its attempt to bring a new cholesterol drug to market after U.S. regulators asked for more information, which could delay the drug's launch for five years. News of the delay comes two months after the U Source: money.cnn.com Biotech-Stock Mailbag: Panacos, Indevus - Street.Com Biotech-Stock Mailbag: Panacos, Indevus - Street.Com
Indevus Pharmaceuticals IDEV and the recent regulatory setback to its long-acting, injectable testosterone product Nebido is on the mind of Robert E., who writes: "I was surprised by the FDA [Food and Drug Administration] response to Nebido as it is Source: www.thestreet.com FDA OKs device tested on Christopher Reeve - USA Today CLEVELAND (AP) — The U.S. Food and Drug Administration has approved a medical device tested on actor Christopher Reeve to help paralyzed people breathe without a ventilator. The device, made by Synapse Biomedical Inc. of Oberlin, Ohio, electrically Source: www.usatoday.com FDA sued for failure to act on risky painkiller - Los Angeles Times WASHINGTON -- A prescription painkiller sold under such names as Darvon and Darvocet is too risky to stay on the market, a consumer advocacy group argued Thursday in suing the Food and Drug Administration. Public Citizen petitioned the FDA two years Source: www.latimes.com FDA says deaths with heart imaging drugs continue - CNN Money NEW YORK (Associated Press) - Despite previous warnings to physicians, drugs used to improve medical images of the heart continue to cause fatal side effects, regulators said Friday. The Food and Drug Administration said that since October it has Source: money.cnn.com RPT-INTERVIEW-US FDA seeks India post for food, drug checks - Reuters AlertNet WASHINGTON, June 19 (Reuters) - The U.S. Food and Drug Administration hopes to establish operations in India by year's end to better police the growing volume of food, medicines, medical devices and animal feed exported to the United States, a top Source: www.alertnet.org UPDATE: Long Delay Seen For Merck's Cholesterol Drug - CNN Money Merck & Co. (MRK) was dealt another setback in its attempt to bring a new cholesterol drug to market after U.S. regulators asked for more information, which could delay the drug's launch for five years. News of the delay comes two months after the U Source: money.cnn.com Merck Provides Update on U.S. Regulatory Status of MK-0524A (ER niacin - MSN MoneyCentral Merck & Co., Inc. today provided an update on the regulatory status in the United States of its investigational medicines MK-0524A (ER niacin/ laropiprant) and MK-0524B (ER niacin/laropiprant/simvastatin) for the treatment of primary Source: news.moneycentral.msn.com Industry backs FDA supplement clamp-down - Nutra Ingredients USA 20-Jun-2008 - The dietary supplements industry has applauded a move by the Food and Drug Administration (FDA) to clamp down on products making bogus cancer cure claims. FDA this week said it had written to 23 companies and two foreign individuals Source: www.nutraingredients-usa.com Analysts: Discovery Labs sell-off overdone - Forbes Analysts: Discovery Labs sell-off overdone - Forbes
Analysts said Thursday investors are overreacting to news that Discovery Laboratories Inc. will delay its response to the Food and Drug Administration's request for information about the company's Surfaxin drug by three months. Last month, the FDA Source: www.forbes.com FDA accused of failure to act on risky painkiller - Fort Lauderdale Sun-Sentinel WASHINGTON - A prescription painkiller sold under such names as Darvon and Darvocet is too risky to stay on the market, a consumer advocacy group argued Thursday in suing the Food and Drug Administration. Public Citizen petitioned the FDA two years Source: www.sun-sentinel.com Pet food stored in filthy conditions seized at Petco hub in Joliet - Chicago Tribune Federal marshals Thursday confiscated pet food at Petco's distribution center in Joliet after U.S. Food and Drug Administration inspectors found the food was stored in unsanitary conditions. FDA employees discovered "widespread and active rodent and Source: www.chicagotribune.com Oncolytics Biotech Inc. Announces U.S. Phase 2 Clinical Trial - Forbes CALGARY, June 20 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) announced today that following U.S. Food and Drug Administration (FDA) review, the Company is initiating a U.S. Phase 2 clinical trial using Source: www.forbes.com Oncolytics Biotech Inc. Announces U.S. Phase 2 Clinical Trial - Forbes Oncolytics Biotech Inc. Announces U.S. Phase 2 Clinical Trial - Forbes
CALGARY, June 20 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) announced today that following U.S. Food and Drug Administration (FDA) review, the Company is initiating a U.S. Phase 2 clinical trial using Source: www.forbes.com GlaxoSmithKline prostate drug combination approved - Forbes British drug maker GlaxoSmithKline PLC said Thursday the Food and Drug Administration approved its enlarged prostate drug Avodart for use in combination with Flomax, which is made by Boehringer Ingelheim Pharmaceuticals Inc. and Astellas Pharma Inc Source: www.forbes.com FDA Warns Companies to Stop Selling Fake Cancer Cures - Atlanta Journal Constitution TUESDAY, June 17 (HealthDay News) -- The U.S. Food and Drug Administration has sent letters warning more than two dozen companies to stop selling fraudulent products that claim to prevent or cure cancer. The agency is also cautioning consumers not to Source: www.ajc.com Glenmark gets FDA nod to market anti-hypertension drug Trandolapril - CNBC LONDON (Thomson Financial) - India's Glenmark Pharmaceuticals Ltd. said its unit Glenmark Generics Ltd. has got Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration for marketing and distribution of Trandolapril Source: www.cnbc.com China's watchdog head stresses quake zone food, drug safety - Xinhua News Agency China's watchdog head stresses quake zone food, drug safety - Xinhua News Agency
BEIJING, June 18 (Xinhua) -- Head of the State Food and Drug Administration Shao Mingli stressed here Wednesday the safety of food and drug in regions hit by the 8.0-magnitude quake on May 12. "Serious punishment should be given immediately to those Source: news.xinhuanet.com Perrigo gets FDA approval for generic Zyrtec Syrup - MSN MoneyCentral Perrigo gets FDA approval for generic Zyrtec Syrup - MSN MoneyCentral
ALLEGAN, Mich. (AP) - Pharmaceutical company Perrigo Co. said Thursday it received final Food and Drug Administration approval for a generic version of Johnson & Johnson's allergic rhinitis treatment, Zyrtec Syrup. J&J's McNeil Consumer Healthcare Source: moneycentral.msn.com YM Biosciences says FDA lifts clinical hold on AeroLEF, clears phase - Forbes MISSISSAUGA, ON (Thomson Financial) - YM BioSciences Inc. said the United States Food and Drug Administration has lifted the clinical hold it imposed in January on the development of YM's AeroLEF acute pain relief based on a formulation of inhaled Source: www.forbes.com Glenmark gets FDA nod to market anti-hypertension drug Trandolapril - CNBC LONDON (Thomson Financial) - India's Glenmark Pharmaceuticals Ltd. said its unit Glenmark Generics Ltd. has got Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration for marketing and distribution of Trandolapril Source: www.cnbc.com FDA OKs breathing device used by Christopher Reeve - Los Angeles Times CLEVELAND -- The Food and Drug Administration on Wednesday approved a medical device tested about five years ago on actor Christopher Reeve to help him breathe without a ventilator. The implantable device, called NeuRx DPS RA/4 Respiratory Source: www.latimes.com FDA sued for failure to act on painkiller - Baltimore Sun A prescription painkiller sold under such names as Darvon and Darvocet is too risky to stay on the market, a consumer advocacy group argued yesterday in suing the Food and Drug Administration. Public Citizen petitioned the FDA two years ago seeking a Source: www.baltimoresun.com Oncolytics Biotech Inc. Announces U.S. Phase 2 Clinical Trial - MSN MoneyCentral CALGARY, June 20 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) announced today that following U.S. Food and Drug Administration (FDA) review, the Company is initiating a U.S. Phase 2 clinical trial using Source: news.moneycentral.msn.com Analysts: Discovery Labs sell-off overdone - Forbes Analysts said Thursday investors are overreacting to news that Discovery Laboratories Inc. will delay its response to the Food and Drug Administration's request for information about the company's Surfaxin drug by three months. Last month, the FDA Source: www.forbes.com RPT-INTERVIEW-US FDA seeks India post for food, drug checks - Reuters India WASHINGTON, June 19 (Reuters) - The U.S. Food and Drug Administration hopes to establish operations in India by year's end to better police the growing volume of food, medicines, medical devices and animal feed exported to the United States, a top Source: in.reuters.com Pet food stored in filthy conditions seized at Petco hub in Joliet - Chicago Tribune Federal marshals Thursday confiscated pet food at Petco's distribution center in Joliet after U.S. Food and Drug Administration inspectors found the food was stored in unsanitary conditions. FDA employees discovered "widespread and active rodent and Source: www.chicagotribune.com FDA Warns Companies to Stop Selling Fake Cancer Cures - Atlanta Journal Constitution FDA Warns Companies to Stop Selling Fake Cancer Cures - Atlanta Journal Constitution
TUESDAY, June 17 (HealthDay News) -- The U.S. Food and Drug Administration has sent letters warning more than two dozen companies to stop selling fraudulent products that claim to prevent or cure cancer. The agency is also cautioning consumers not to Source: www.ajc.com June 19, 2008Atrium Initiates Voluntary Recall Action Regarding HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters used for Autotransfusion during Cardiopulmonary Bypass Surgery (May 12) Atrium Initiates Voluntary Recall Action Regarding HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters used for Autotransfusion during Cardiopulmonary Bypass Surgery (May 12)
Atrium Medical Corporation today announced that it is initiating a voluntary and precautionary recall of selected lots of HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters. Limited lots of Atrium heparin-coated Hydraglide Thoracic Catheters were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate. Tipu's Tiger Chai, Inc Recalls Tipus Tiger Chai Concentrate Because of a Possible Health Risk (June 17) Tipu's Tiger Chai Inc, of Missoula, Montana is voluntarily recalling its Tipu's Tiger Chai Concentrate because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled. Orval Kent Foods Recalls Single Limited Production Run of Amish Macaroni Salad Sold Under the Orval Kent and Yoder’s Brand Names (May 28) Orval Kent Foods is voluntarily recalling approximately 23,000 pounds of Amish Macaroni Salad that may pose a health risk. This voluntary action is being taken in response to the results of a test conducted on a single package of Amish Macaroni Salad by the Ohio Department of Agriculture and Consumer Services, Division of Food Safety, for E. coli O157:H7. Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial FDA 101: How to Use the Consumer Complaint System and MedWatch When you have a problem with a food, drug, or other FDA-regulated product, FDA wants to hear from you. Here's how to report problems using two of FDA's main reporting systems. Drug to be Discontinued: Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension) Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension), Dear Healthcare Professional Letter available for more information. Warning on Certain Types of Raw Red Tomatoes FDA is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes. FDA, European Medicines Agency to Consider Additional Test Results When Assessing New Drug Safety FDA, European Medicines Agency to Consider Additional Test Results When Assessing New Drug Safety
In the first use of a framework allowing submission of a single application to the two agencies, the Food and Drug Administration (FDA) and the European Medicines Association (EMEA) worked together to allow drug companies to submit the results of seven new tests that evaluate kidney damage during animal studies of new drugs. The tests measure the levels of seven key proteins or "biomarkers" found in urine that can provide additional information about drug-induced damage to kidney cells, also known as renal toxicity. FDA Warns Consumers in New Mexico and Texas Not to Eat Certain Types of Raw Red Tomatoes The Food and Drug Administration is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes. The bacteria causing the illnesses are Salmonella serotype Saintpaul, an uncommon type of Salmonella. FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these raw, red tomatoes. FDA Advises Patients to Switch to HFA-Propelled Albuterol Inhalers Now CFC-propelled albuterol inhalers are being phased out because they are harmful to the environment by contributing to depletion of the ozone layer above the Earth's surface. FDA sued for failure to act on risky painkiller - Miami Herald FDA sued for failure to act on risky painkiller - Miami Herald
A prescription painkiller sold under such names as Darvon and Darvocet is too risky to stay on the market, a consumer advocacy group argued Thursday in suing the Food and Drug Administration. Public Citizen petitioned the FDA two years ago seeking a Source: www.miamiherald.com Vertex CEO preparing for '09 hepatitis drug launch - Reuters SAN DIEGO, June 19 (Reuters) - Vertex Pharmaceuticals Inc (VRTX.O: Quote , Profile , Research , Stock Buzz ) will be prepared to launch its experimental hepatitis C drug next year even though U.S. regulators have not said whether they would review it Source: www.reuters.com Discovery Labs' Surfaxin response to FDA delayed - Forbes Discovery Labs' Surfaxin response to FDA delayed - Forbes
Discovery Laboratories Inc. said Thursday it plans to respond in September - much later than previously announced - to a Food and Drug Administration request for more information on its Surfaxin respiratory distress syndrome drug for premature Source: www.forbes.com FDA sued for failure to act on risky painkiller - Miami Herald A prescription painkiller sold under such names as Darvon and Darvocet is too risky to stay on the market, a consumer advocacy group argued Thursday in suing the Food and Drug Administration. Public Citizen petitioned the FDA two years ago seeking a Source: www.miamiherald.com FDA issues warning to companies that claim cures for cancer - Seattle Times WASHINGTON — Tumorex, Immune Ace, Ellagic Insurance Formula, PC Hope, Pacific Ocean Shark Cartilage, Breast Cancer Tea Formula. They are all products sold to desperate cancer patients or people worried they might become one. On Tuesday, the Food Source: seattletimes.nwsource.com FDA OKs breathing device used by Christopher Reeve - Los Angeles Times CLEVELAND -- The Food and Drug Administration on Wednesday approved a medical device tested about five years ago on actor Christopher Reeve to help him breathe without a ventilator. The implantable device, called NeuRx DPS RA/4 Respiratory Source: www.latimes.com FDA Panel Recommends Enbrel for Pediatric Patients - Washington Post Resize Text WEDNESDAY, June 18 (HealthDay News) -- A U.S. Food and Drug Administration advisory panel recommended Wednesday that the psoriasis drug Enbrel be approved for use in children who have moderate-to-severe forms of the skin disease. The Source: www.washingtonpost.com EnteroMedics' Data from VBLOC-RF2 Feasibility Study and VBLOC-RC - MSN MoneyCentral EnteroMedics Inc. ETRM , the developer of medical devices using neuroblocking technology to treat obesity and other gastrointestinal disorders, announced that interim clinical results for the company's VBLOC ™ vagal blocking therapy device, the Source: news.moneycentral.msn.com FDA seizes pet food products from PETCO - United Press International WASHINGTON, June 19 (UPI) -- U.S. marshals say they have seized various pet food products stored under unsanitary conditions at a Petco distribution center in Joliet, Ill. The U.S. Food and Drug Administration requested the action under a federal Source: www.upi.com FDA issues warning to companies that claim cures for cancer - Seattle Times FDA issues warning to companies that claim cures for cancer - Seattle Times
WASHINGTON — Tumorex, Immune Ace, Ellagic Insurance Formula, PC Hope, Pacific Ocean Shark Cartilage, Breast Cancer Tea Formula. They are all products sold to desperate cancer patients or people worried they might become one. On Tuesday, the Food Source: seattletimes.nwsource.com Senator Wants FDA Probe of India, China Pharma - BusinessWeek by Deepshikha Monga and Khomba Singh Outsourcing has come under the US scanner once again, this time for drug manufacturing. The US Food & Drug Administration (FDA) has been asked by a US senator to probe into outsourcing of pharmaceutical Source: www.businessweek.com FDA clears Baja California tomatoes - Thepacker.com (June 17, UPDATED, 12:44 p.m.) The Food and Drug Administration has cleared Baja California just in time for the Mexican state to start shipping roma tomatoes to the U.S. Vice president of sales John King said June 16 that Andrew & Williamson Fresh Source: thepacker.com Start at the Store: 7 Ways to Prevent Foodborne Illness Start at the Store: 7 Ways to Prevent Foodborne Illness
Food safety for consumers should begin at the supermarket or grocery store. Here are useful hints to keep in mind when shopping for food that will help keep foodborne illnesses out of your home. Bayer Removes Remaining Trasylol Stock Bayer will begin removing the remaining Trasylol, a drug used to control bleeding during heart surgery, from the U.S. market. Drug to be Discontinued: Kemadrin (procyclidine hydrochloride) Drug to be Discontinued: Kemadrin (procyclidine hydrochloride)
Kemadrin (procyclidine hydrochloride), Dear Healthcare Professional Letter available for more information. FDA Takes Action against Seafood Processing Company, Executives The U.S. Food and Drug Administration today filed a complaint for permanent injunction against seafood processor Captain's Select Seafood, Inc., Minneapolis, Minn., and two of its top officers for violating the Federal Food, Drug and Cosmetic Act. FDA Approves Diaphragm-Pacing Device The U.S. Food and Drug Administration today announced that it approved the NeuRx DPS RA/4 Respiratory Stimulation System, an implantable electronic device that stimulates the diaphragm and allows certain spinal cord injury patients to breathe for at least four hours a day without a mechanical ventilator. June 18, 2008FDA warns against fake cancer cures - United Press International FDA warns against fake cancer cures - United Press International
WASHINGTON, June 19 (UPI) -- The U.S. Food and Drug Administration says it is cracking down on the sale of products that fraudulently claim to prevent or cure cancer. The products contain ingredients such as bloodroot, shark cartilage, coral calcium Source: www.upi.com Device To Aid Breathing Gets FDA OK - Tampa Bay Online CLEVELAND - The Food and Drug Administration on Wednesday approved a medical device tested about five years ago on actor Christopher Reeve to help him breathe without a ventilator. The implantable device, called NeuRx DPS RA/4 Respiratory Stimulation Source: www2.tbo.com FDA OKs breathing device tested on Christopher Reeve - Detroit Free Press CLEVELAND — The Food and Drug Administration today approved a medical device tested about five years ago on actor Christopher Reeve to help him breathe without a ventilator. The implantable device, called NeuRx DPS RA/4 Respiratory Stimulation Source: www.freep.com FDA OKs breathing device tested by Christopher Reeve - New York Daily News FDA OKs breathing device tested by Christopher Reeve - New York Daily News
The experimental breathing device tested by Christopher Reeve is now approved for general use. CLEVELAND - The Food and Drug Administration on Wednesday approved a medical device tested about five years ago on actor Christopher Reeve to help him Source: www.nydailynews.com 6 new tainted tomato cases confirmed in NYC - MSNBC NEW YORK - Federal health officials have learned of 106 more cases of salmonella linked to tainted tomatoes, putting the outbreak’s toll at 383 on Wednesday and counting. “We do not think the outbreak is over,” said Dr. Robert Tauxe of the Source: www.msnbc.msn.com FDA backs wider use of Amgen drug for kids - Reuters SILVER SPRING, Maryland (Reuters) - U.S. health officials should approve wider use of Amgen Inc's drug Enbrel to treat psoriasis in children, a Food and Drug Administration advisory panel said on Wednesday. But the panel was divided over whether to Source: www.reuters.com FDA OKs breathing device used by Christopher Reeve - Chicago Tribune CLEVELAND - The Food and Drug Administration on Wednesday approved a medical device tested about five years ago on actor Christopher Reeve to help him breathe without a ventilator. The implantable device, called NeuRx DPS RA/4 Respiratory Stimulation Source: www.chicagotribune.com Letter of the day: Give the FDA the tools to keep us safe - Minneapolis Star Tribune Letters to the editor for Wednesday, June 18 Letter of the day: Readers remember Tim Russert Letters to the editor for Tuesday, June 17 Letters to the editor for Monday, June 16 Burnsville: Build the park, but grab the Saints No country in the world Source: www.startribune.com CDC counts 383 salmonella cases from tomatoes - Chicago Tribune WASHINGTON - Federal health officials have learned of 106 more cases of salmonella linked to tainted tomatoes, putting the outbreak's toll at 383 on Wednesday and counting. "We do not think the outbreak is over," said Dr. Robert Tauxe of the Centers Source: www.chicagotribune.com More salmonella cases tied to tomatoes - CNN (CNN) -- The number of cases of sickness caused by tomatoes has risen in recent days; 383 people have been infected with a rare form of salmonella since April in 30 states and the District of Columbia, federal health officials said Wednesday. At Source: www.cnn.com FDA issues warning to companies that claim cures for cancer - Seattle Times WASHINGTON — Tumorex, Immune Ace, Ellagic Insurance Formula, PC Hope, Pacific Ocean Shark Cartilage, Breast Cancer Tea Formula. They are all products sold to desperate cancer patients or people worried they might become one. On Tuesday, the Food Source: seattletimes.nwsource.com Start at the Store: 7 Ways to Prevent Foodborne Illness Start at the Store: 7 Ways to Prevent Foodborne Illness
Food safety for consumers should begin at the supermarket or grocery store. Here are useful hints to keep in mind when shopping for food that will help keep foodborne illnesses out of your home. FDA Announces New Labeling Changes for Regranex The U.S. Food and Drug Administration today announced the addition of a boxed warning to the label of Regranex Gel 0.01 percent (becaplermin) to address the increased risk of cancer mortality in patients who use 3 or more tubes of the product. Regranex is a topical cream indicated for the treatment of leg and foot ulcers that are not healing in diabetic patients. FDA Warns Consumers in New Mexico and Texas Not to Eat Certain Types of Raw Red Tomatoes The Food and Drug Administration is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes. The bacteria causing the illnesses are Salmonella serotype Saintpaul, an uncommon type of Salmonella. FDA Safety Update: Asthma Medications May is Asthma and Allergy Awareness Month. Here is a roundup of recent safety issues related to asthma medications. Warning for Regranex—Cream for Leg and Foot Ulcers A boxed warning has been added to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer death in patients who use three or more tubes of the product. FDA Takes Action Against Scientific Laboratories Inc. A permanent injunction bars Scientific Laboratories from making and distributing drug products until its manufacturing operations comply with law and its products are approved. FDA Requests Recall of Xiadafil VIP Tabs The U.S. Food and Drug Administration today requested that SEI Pharmaceuticals, of Miami, Fla., recall all Xiadafil VIP Tabs sold in 8 tablet bottles (Lot # 6K029) or blister cards of 2 tablets (Lot # 6K029-SEI) because these products contain a potentially harmful, undeclared ingredient that may dangerously affect a person's blood pressure and can cause other life-threatening side effects. Recalls and Safety Alerts: Neupro Patches Recalled Recalls and Safety Alerts: Neupro Patches Recalled
Schwarz Pharma recalled Neupro (rotigotine) transdermal patches at the end of April 2008. These patches are used to treat early stage Parkinson's disease. The problem is that rotigotine, the active ingredient, may crystallize in the patch. If th... Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial Patients Are Asking: Getting the Most Out of Blood Glucose Meters Keeping glucose levels under control can help people with diabetes feel better and also lower the risk of blindness, kidney disease, and nerve damage. Very high or very low blood sugar can have serious consequences. Although blood glucose meter... Drug Shortage: Digitek (digoxin tablets, USP) Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.) recalled of all lots of Bertek and UDL Laboratories Digitek (digoxin tablets, USP). Other manufacturers of digoxin tablets are available and listed on the Drug Shortage website. Viril-ity Power (VIP) Tablets Product recalled because it contains a potentially harmful, undeclared ingredient that may interact with nitrates found in some prescription drugs and can lower blood pressure to life-threatening levels. Mommy's Bliss Nipple Cream Product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants. Current Drug Shortage: Levothyroxine sodium lyophilized powder for injection. Bedford has the 200 mcg vials (NDC 55390-0880-10) available. APP plans to have levothyroxine vials available again Drug to be Discontinued: Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP) Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP), Dear Healthcare Professional Letter available for more information. Recalls and Safety Alerts: Inflammatory Masses with Synchromed and IsoMed Implantable Infusion Pumps On January 16, 2008, Medtronic notified healthcare professionals about an increased rate of inflammatory masses in patients receiving intrathecal drugs through the company's Synchromed EL, Synchromed II and IsoMed implantable infusion pump systems. ... FDA Proposes New Rule to Provide Updated Information on the Use of Prescription Drugs and Biological Products during Pregnancy and Breast-feeding FDA Proposes New Rule to Provide Updated Information on the Use of Prescription Drugs and Biological Products during Pregnancy and Breast-feeding
The proposed changes to prescription drug labeling would give health care professionals more comprehensive information for making prescribing decisions and for counseling women who are pregnant, breast-feeding, or of child-bearing age about using prescription medications. FDA Takes Action against Seafood Processing Company, Executives FDA Takes Action against Seafood Processing Company, Executives
The U.S. Food and Drug Administration today filed a complaint for permanent injunction against seafood processor Captain's Select Seafood, Inc., Minneapolis, Minn., and two of its top officers for violating the Federal Food, Drug and Cosmetic Act. Morphine Sulfate 60 mg and 30 mg Extended Release Tablets UPDATE - Additional lots of morphine sulfate 60 mg extended release tablets, and specific lots of morphine sulfate 30 mg extended release tablets, were recalled due to the possible presence of oversized tablets. Patients Are Asking: Getting the Most Out of Blood Glucose Meters Keeping glucose levels under control can help people with diabetes feel better and also lower the risk of blindness, kidney disease, and nerve damage. Very high or very low blood sugar can have serious consequences. Although blood glucose meter... FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs The U.S. Food and Drug Administration today exercised its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to require manufacturers of "conventional" antipsychotic drugs to make safety-related changes to prescribing information, or labeling, to warn about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia. June 2008 Patient Safety News Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. Recalls and Safety Alerts: Inflammatory Masses with Synchromed and IsoMed Implantable Infusion Pumps On January 16, 2008, Medtronic notified healthcare professionals about an increased rate of inflammatory masses in patients receiving intrathecal drugs through the company's Synchromed EL, Synchromed II and IsoMed implantable infusion pump systems. ... FDA OKs device tested on Christopher Reeve - USA Today FDA OKs device tested on Christopher Reeve - USA Today
CLEVELAND (AP) — The U.S. Food and Drug Administration has approved a medical device tested on actor Christopher Reeve to help paralyzed people breathe without a ventilator. The device, made by Synapse Biomedical Inc. of Oberlin, Ohio, electrically Source: www.usatoday.com FDA panel says Amgen skin drug benefits children - CNN Money NEW YORK (Associated Press) - A panel of government experts on Wednesday said the benefits of Amgen Inc.'s drug Enbrel outweigh its risks for treating children with a serious skin disease. The Food and Drug Administration's panel of dermatology Source: money.cnn.com U.S. FDA hopes to open China offices by year end - Reuters ANNAPOLIS, Md, June 17 (Reuters) - China has granted diplomatic approval for the U.S. Food and Drug Administration to open three inspections offices in China that also will help increase China's capacity for safe foods, drugs and medical devices, a Source: www.reuters.com Mexican farmers angry over FDA salmonella probe - Miami Herald Mexican farmers are mad enough to throw, well, rotten tomatoes at the U.S. Food and Drug Administration, which is focusing heavily on Mexico as a potential source of the fruit that has sickened hundreds of people in the United States with salmonella Source: www.miamiherald.com FDA panel supports Amgen's Enbrel for kids - Reuters SILVER SPRING, Maryland (Reuters) - U.S. health officials should approve wider use of Amgen Inc's drug Enbrel to treat psoriasis in children, a Food and Drug Administration advisory panel said on Wednesday. In an 8-5 vote, the FDA's panel of outside Source: www.reuters.com FDA Warns Companies to Stop Selling Fake Cancer Cures - WAFF TUESDAY, June 17 (HealthDay News) -- The U.S. Food and Drug Administration has sent letters warning more than two dozen companies to stop selling fraudulent products that claim to prevent or cure cancer. The agency is also cautioning consumers not to Source: www.waff.com FDA Approves Breathing Device Tested on 'Superman' Reeves - FOX News The Food and Drug Administration on Wednesday approved a medical device tested about five years ago on actor Christopher Reeve to help him breathe without a ventilator. The implantable device, called NeuRx DPS RA/4 Respiratory Stimulation System and Source: www.foxnews.com FDA OKs breathing device tested on Christopher Reeve - BusinessWeek The Food and Drug Administration on Wednesday approved a medical device tested about five years ago on actor Christopher Reeve to help him breathe without a ventilator. The implantable device, called NeuRx DPS RA/4 Respiratory Stimulation System and Source: www.businessweek.com Albuterol Inhalers: Time to Transition Albuterol Inhalers: Time to Transition
Manufacturers have been directed to phase out albuterol inhalers that use chlorofluorocarbons (CFCs)--propellants that deplete the ozone layer. Here are facts about switching to alternative inhalers that use hydrofluoroalkane (HFA) propellants. Start at the Store: 7 Ways to Prevent Foodborne Illness Food safety for consumers should begin at the supermarket or grocery store. Here are useful hints to keep in mind when shopping for food that will help keep foodborne illnesses out of your home. Important Information about Albuterol Metered Dose Inhalers (MDIs) After December 31, 2008, albuterol CFC MDIs are prohibited from being sold or distributed in the United States. Therefore, patients are encouraged to talk with their health care providers now to begin the transition to an HFA propelled albuterol MDI. After the transition is complete, it is anticipated that supplies of albuterol HFA and levalbuterol HFA MDIs will continue to meet the total market demand. FDA is working closely with manufacturers to ensure that there is adequate supply of the HFA propelled albuterol and levalbuterol MDI products available. (more information) Drug to be Discontinued: Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP) Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP), Dear Healthcare Professional Letter available for more information. Pregnant Women to Benefit from Better Information A proposed rule will give women and their health care professionals better information concerning the effects of medications taken during pregnancy or while breastfeeding. Drug to be Discontinued: Intal Nebulizer Solution (cromolyn sodium inhalation solution, USP) Intal Nebulizer Solution (cromolyn sodium inhalation solution, USP. Dear Healthcare Professional Letter is available for more information. Contaminated Nipple Cream FDA is warning nursing mothers not to buy or use Mommy's Bliss Nipple Cream because it contains potentially harmful ingredients. Controlling Cholesterol with Statins When diet and exercise alone are not enough to reduce cholesterol to goal levels, doctors often prescribe statin medications. These drugs can reduce the risk of heart attack, stroke, and death. FDA Takes Action against Seafood Processing Company, Executives FDA Takes Action against Seafood Processing Company, Executives
The U.S. Food and Drug Administration today filed a complaint for permanent injunction against seafood processor Captain's Select Seafood, Inc., Minneapolis, Minn., and two of its top officers for violating the Federal Food, Drug and Cosmetic Act. Supreme Cuts Announces Voluntary Recall of Small Sample of Off The Cob Fresh Kernel Corn (May 27) As a precautionary measure, Supreme Cuts LLC has announced that it is voluntarily recalling 87 cases of Off the Cob Fresh Kernel Corn in 12 oz bags. The product may be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail and elderly people, and others with weakened immune systems. Medtronic Initiates Voluntary Field Actions for Selected Heparin-Coated Products Used During Cardiopulmonary Bypass (May 7) Medtronic, Inc. announced that it is initiating a voluntary and precautionary recall of selected products featuring the Carmeda BioActive surface. The affected devices are disposable products used during cardiopulmonary bypass (CPB) for heart surgeries. Affected products include blood oxygenators, reservoirs, pumps, cannulae, and tubing packs. Viril-ity Power (VIP) Tablets Product recalled because it contains a potentially harmful, undeclared ingredient that may interact with nitrates found in some prescription drugs and can lower blood pressure to life-threatening levels. FDA Warns Consumers in New Mexico and Texas Not to Eat Certain Types of Raw Red Tomatoes The Food and Drug Administration is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes. The bacteria causing the illnesses are Salmonella serotype Saintpaul, an uncommon type of Salmonella. FDA Expands Anti-Psychotic Drug Warning - The Bulletin FDA Expands Anti-Psychotic Drug Warning - The Bulletin
The U.S. Food and Drug Administration (FDA) will soon be increasing the number of prescription anti-psychotic drugs to carry a special warning label. The label will warn against side effects, particularly for those over 65 based on recent studies Source: www.thebulletin.us FDA OKs device tested on Christopher Reeve - CNBC CLEVELAND - The U.S. Food and Drug Administration has approved a medical device tested on actor Christopher Reeve to help paralyzed people breathe without a ventilator. The device, made by Synapse Biomedical Inc. of Oberlin, Ohio, electrically Source: www.cnbc.com Allergan wins FDA approval for retinal injection - CNN Money NEW YORK (Associated Press) - Allergan Inc. late Monday said it received Food and Drug Administration approval for an injectable eye drug to treat retinal diseases. Trivaris, which is injected directly into the eye, is a steroid that reduces Source: money.cnn.com FDA Approves Cymbalta For Fibromyalgia - Post Chronicle Eli Lilly and Co. said the U.S. Food and Drug Administration has approved duloxetine HCl, marketed under the name Cymbalta, for fibromyalgia. The Indianapolis drug maker said Cymbalta is the first serotonin-norepinephrine reuptake inhibitor proven to Source: www.postchronicle.com China enhances attack on doping agents production, sale ahead of - Xinhua News Agency BEIJING, June 18 (Xinhua) -- China has punished 125 medicine companies for illegally producing and distributing doping agents since launching a nationwide campaign last year to ensure a drug-free Olympic Games, said a senior drug official on Source: news.xinhuanet.com FDA Says No to ‘Miraculous’ Cancer ‘Cures’ - Eflux Media The U.S. Food and Drug Administration is cautioning consumers not to purchase fraudulent products (tablets, teas, tonics, black salves and creams) that claim to prevent or cure various cancers. The heath agency said it had already sent warning Source: www.efluxmedia.com Official: Most China-made performance-enhancing drug ingredients - Xinhua News Agency BEIJING, June 18 (Xinhua) -- China's drug watchdog refuted reports on the country's alleged large amount of performance-enhancing drug ingredients exports on Wednesday, saying most China-made ingredients that can be used in making the drugs were Source: news.xinhuanet.com UPDATE: Ranbaxy Executive:To Get 180-Day Exclusivity For Lipitor - CNN Money BANGALORE -(Dow Jones)- Ranbaxy Laboratories Ltd. (500359.BY), India's biggest drug maker by revenue, will retain the right to exclusively market its generic version of Pfizer Inc.'s (PFE) blockbuster cholesterol drug Lipitor for 180 days in the U.S Source: money.cnn.com Seattle Genetics Achieves Milestone Under Antibody-Drug Conjugate - MSN MoneyCentral Seattle Genetics, Inc. SGEN , announced today that it has achieved a milestone under its antibody-drug conjugate (ADC) collaboration with Genentech, Inc. The milestone was triggered by Genentech ’ s filing of an Investigational New Drug (IND Source: news.moneycentral.msn.com Mylan gets final FDA OK for generic antidepressant - CNN Money NEW YORK (Associated Press) - Drug developer Mylan Inc. said Monday the Food and Drug Administration granted final approval for the generic version of Wyeth's antidepressant Effexor. Mylan said it will begin shipping its version of the drug Source: money.cnn.com Tipu's Tiger Chai, Inc Recalls Tipus Tiger Chai Concentrate Because of a Possible Health Risk (June 17) Tipu's Tiger Chai, Inc Recalls Tipus Tiger Chai Concentrate Because of a Possible Health Risk (June 17)
Tipu's Tiger Chai Inc, of Missoula, Montana is voluntarily recalling its Tipu's Tiger Chai Concentrate because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled. FDA warns sellers of cancer cures - Baltimore Sun FDA warns sellers of cancer cures - Baltimore Sun
WASHINGTON - In an effort to crack down on fraudulent remedies, the government has warned 25 companies to stop selling cancer cures over the Internet that federal health officials say could disrupt legitimate treatment and even harm unsuspecting Source: www.baltimoresun.com FDA Orders Warning Label on Older Antipsychotics - Atlanta Journal Constitution MONDAY, June 16 (HealthDay News) -- The U.S. Food and Drug Administration is cautioning physicians that certain types of antipsychotic drugs can boost the death risk of seniors with dementia. Doctors sometimes use antipsychotics to help treat Source: www.ajc.com FDA warns of bogus cancer treatments - Hampton Roads Daily Press The Food and Drug Administration is cracking down on teas, supplements, creams and other products that falsely claim to cure, treat or prevent cancer even though they are not agency-approved drugs. All are available for sale on the Internet. The Source: www.dailypress.com FDA puts kibosh on 'healers' - Raleigh News & Observer Story Tools WASHINGTON - Tumorex, Immune Ace, Ellagic Insurance Formula, PC Hope, Pacific Ocean Shark Cartilage, Breast Cancer Tea Formula. They are all products sold to desperate cancer patients or people worried they might be affected. On Tuesday Source: www.newsobserver.com U.S. FDA warns maker over Icy Hot patches - HealthCentral.com WASHINGTON (Reuters) - Chattem Inc. failed to notify U.S. health officials about new cautions added to its Icy Hot heat therapy patches after getting more than 168 complaints, according to a letter released Tuesday. In a warning letter to the company Source: www.healthcentral.com Allergan wins FDA approval for retinal injection - MSN MoneyCentral IRVINE, Calif. (AP) - Allergan Inc. late Monday said it received Food and Drug Administration approval for an injectable eye drug to treat retinal diseases. Trivaris, which is injected directly into the eye, is a steroid that reduces inflammation of Source: news.moneycentral.msn.com FDA approves Cymbalta for Fibromyalgia - The Money Times Indianapolis -- Eli Lilly and Co. said the U.S. Food and Drug Administration has approved duloxetine HCl, marketed under the name Cymbalta, for fibromyalgia. The Indianapolis drug maker said Cymbalta is the first serotonin-norepinephrine reuptake Source: www.themoneytimes.com El Paso chefs don't shy away from tomatoes - El Paso Times The Food and Drug Administration has all but labeled the tomato as "the forbidden fruit." Red plum, Roma and round tomatoes were found to have salmonella, sickening more than 275 people across the country. The FDA says cherry and grape tomatoes sold Source: www.elpasotimes.com FDA issues warning to companies that claim cures for cancer - Seattle Times WASHINGTON — Tumorex, Immune Ace, Ellagic Insurance Formula, PC Hope, Pacific Ocean Shark Cartilage, Breast Cancer Tea Formula. They are all products sold to desperate cancer patients or people worried they might become one. On Tuesday, the Food Source: seattletimes.nwsource.com U.S. FDA expands antipsychotic drug warning - Reuters U.S. FDA expands antipsychotic drug warning - Reuters
WASHINGTON (Reuters) - Older, conventional antipsychotic medications should carry a "black box" warning about an increased risk of death in some elderly people being treated for dementia-related psychosis, the U.S. Food and Drug Administration said Source: www.reuters.com Allergan wins FDA approval for retinal injection - MSN MoneyCentral IRVINE, Calif. (AP) - Allergan Inc. late Monday said it received Food and Drug Administration approval for an injectable eye drug to treat retinal diseases. Trivaris, which is injected directly into the eye, is a steroid that reduces inflammation of Source: news.moneycentral.msn.com FDA warns sellers of cancer cures - Baltimore Sun WASHINGTON - In an effort to crack down on fraudulent remedies, the government has warned 25 companies to stop selling cancer cures over the Internet that federal health officials say could disrupt legitimate treatment and even harm unsuspecting Source: www.baltimoresun.com Tracking the bug in tomatoes - Chicago Tribune David Acheson is the nation's top food detective, but so far he has met his match in the wily tomato. With the salmonella scare that has plagued tomatoes, Acheson has faced perhaps his biggest test—at least as far as outbreaks of illness go—since Source: www.chicagotribune.com FDA Orders Warning Label on Older Antipsychotics - Atlanta Journal Constitution MONDAY, June 16 (HealthDay News) -- The U.S. Food and Drug Administration is cautioning physicians that certain types of antipsychotic drugs can boost the death risk of seniors with dementia. Doctors sometimes use antipsychotics to help treat Source: www.ajc.com June 17, 2008Mylan gets final FDA OK for generic antidepressant - CNN Money Mylan gets final FDA OK for generic antidepressant - CNN Money
NEW YORK (Associated Press) - Drug developer Mylan Inc. said Monday the Food and Drug Administration granted final approval for the generic version of Wyeth's antidepressant Effexor. Mylan said it will begin shipping its version of the drug Source: money.cnn.com FDA Moves Against Products Making False Cancer Claims - Wall Street Journal WASHINGTON -- The Food and Drug Administration is cracking down on teas, supplements, creams and other products that falsely claim to cure, treat or prevent cancer even though they aren't agency-approved drugs. All are available for sale on the Source: online.wsj.com Allergan wins FDA approval for retinal injection - CNN Money NEW YORK (Associated Press) - Allergan Inc. late Monday said it received Food and Drug Administration approval for an injectable eye drug to treat retinal diseases. Trivaris, which is injected directly into the eye, is a steroid that reduces Source: money.cnn.com Attack of the iller tomatoes - Boston Globe A 28-STATE outbreak of salmonella poisoning caused by raw tomatoes has exposed once again the inability of the US Food and Drug Administration to protect the public from contaminated food, adulterated medicines, and defective medical devices. A Source: www.boston.com FDA approves Cymbalta for Fibromyalgia - United Press International INDIANAPOLIS, June 18 (UPI) -- Eli Lilly and Co. said the U.S. Food and Drug Administration has approved duloxetine HCl, marketed under the name Cymbalta, for fibromyalgia. The Indianapolis drug maker said Cymbalta is the first serotonin Source: www.upi.com U.S. FDA hopes to open China offices by year end - Reuters ANNAPOLIS, Md, June 17 (Reuters) - China has granted diplomatic approval for the U.S. Food and Drug Administration to open three inspections offices in China that also will help increase China's capacity for safe foods, drugs and medical devices, a Source: www.reuters.com FDA cracks down on 'cancer cures' - CNN WASHINGTON (AP) -- The Food and Drug Administration is cracking down on teas, supplements, creams and other products that falsely claim to cure, treat or prevent cancer even though they are not agency-approved drugs. All are available for sale on the Source: www.cnn.com FDA hits fake cures for cancer on Web - Boston Globe WASHINGTON - In an effort to crack down on fraudulent remedies, the government has warned 25 companies to stop selling cancer cures online. Health officials say such commerce could disrupt legitimate treatment and harm patients. Food and Drug Source: www.boston.com FDA: Beware of Fake Cancer Treatments - Time (WASHINGTON) — The Food and Drug Administration is cracking down on teas, supplements, creams and other products that falsely claim to cure, treat or prevent cancer even though they are not agency-approved drugs. All are available for sale on the Source: www.time.com Viril-ity Power (VIP) Tablets Viril-ity Power (VIP) Tablets
Product recalled because it contains a potentially harmful, undeclared ingredient that may interact with nitrates found in some prescription drugs and can lower blood pressure to life-threatening levels. Morphine Sulfate 60 mg and 30 mg Extended Release Tablets UPDATE - Additional lots of morphine sulfate 60 mg extended release tablets, and specific lots of morphine sulfate 30 mg extended release tablets, were recalled due to the possible presence of oversized tablets. Mommy's Bliss Nipple Cream Product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants. FDA, European Medicines Agency to Consider Additional Test Results When Assessing New Drug Safety In the first use of a framework allowing submission of a single application to the two agencies, the Food and Drug Administration (FDA) and the European Medicines Association (EMEA) worked together to allow drug companies to submit the results of seven new tests that evaluate kidney damage during animal studies of new drugs. The tests measure the levels of seven key proteins or "biomarkers" found in urine that can provide additional information about drug-induced damage to kidney cells, also known as renal toxicity. Calcilo XD Low-Calcium Vitamin D-Free Infant Formula With Iron Powder Product recalled because of possible oxidation that can cause gastrointestinal symptoms in infants. Morphine Sulfate 60 mg Extended Release Tablets Voluntarily recall of a single lot (No. 91762) due to a report of a tablet with twice the appropriate thickness. FDA Warns Consumers in New Mexico and Texas Not to Eat Certain Types of Raw Red Tomatoes The Food and Drug Administration is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes. The bacteria causing the illnesses are Salmonella serotype Saintpaul, an uncommon type of Salmonella. Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia) FDA investigating TNF blockers and cancer risk in children and young adults. Recalls and Safety Alerts: FDA Studying Potential Safety Issues with Several Drugs FDA has informed the health care community about ongoing safety reviews of several drugs. FDA is doing this as part of its commitment to inform health care professionals and the public about its ongoing drug safety reviews. Because this information... FDA: Beware of Fake Cancer Treatments - Time FDA: Beware of Fake Cancer Treatments - Time
(WASHINGTON) — The Food and Drug Administration is cracking down on teas, supplements, creams and other products that falsely claim to cure, treat or prevent cancer even though they are not agency-approved drugs. All are available for sale on the Source: www.time.com Letter of the day: Give the FDA the tools to keep us safe - Minneapolis Star Tribune Letters to the editor for Wednesday, June 18 Letter of the day: Readers remember Tim Russert Letters to the editor for Tuesday, June 17 Letters to the editor for Monday, June 16 Burnsville: Build the park, but grab the Saints No country in the world Source: www.startribune.com FDA Panel Recommends Approval For J&J Psoriasis Drug - All Headline News Washington, D.C. (AHN) - Johnson & Johnson's proposed psoriasis drug ustekinumab took the first step toward approval Tuesday when a Food and Drug Administration panel recommended the drug. The panel does have some long-term concerns that use of the Source: www.allheadlinenews.com FDA warns about fraudulent cancer treatments - Syracuse Post-Standard WASHINGTON (AP) — The Food and Drug Administration is cracking down on teas, supplements, creams and other products that falsely claim to cure, treat or prevent cancer even though they are not agency-approved drugs. All are available for sale on Source: www.syracuse.com FDA cracks down on 'cancer cures' - CNN WASHINGTON (AP) -- The Food and Drug Administration is cracking down on teas, supplements, creams and other products that falsely claim to cure, treat or prevent cancer even though they are not agency-approved drugs. All are available for sale on the Source: www.cnn.com Mylan Announces Tentative FDA Approval for Generic Version of - Forbes PITTSBURGH, June 16 /PRNewswire-FirstCall/ -- Mylan Inc. (NYSE: MYL) today announced that its subsidiary, Mylan Pharmaceuticals Inc., has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Source: www.forbes.com FDA targets cancer cure 'scammers' online - News-Medical.Net The FDA also warns North American consumers against using or purchasing the products, which include tablets, teas, tonics, black salves, and creams, and are sold under various names on the Internet. Those companies and individuals warned, the Source: www.news-medical.net FDA cracks down on 'cancer cures' - CNN FDA cracks down on 'cancer cures' - CNN
WASHINGTON (AP) -- The Food and Drug Administration is cracking down on teas, supplements, creams and other products that falsely claim to cure, treat or prevent cancer even though they are not agency-approved drugs. All are available for sale on the Source: www.cnn.com UPDATE: FDA Panel Recommends Approval For J&J Psoriasis Drug - CNN Money unanimously recommended approval of a Johnson & Johnson (JNJ) drug proposed for treatment of severe-to-moderate psoriasis, but said more data is needed to determine whether the drug increases the risk of cancer and infections. Despite those concerns Source: money.cnn.com FDA: Part of Mexico cleared in salmonella probe - Los Angeles Times WASHINGTON -- One part of Mexico -- Baja California -- has been cleared of suspicion in the outbreak of salmonella-tainted tomatoes, which U.S. officials said Monday now has sickened 277 people. That's 49 more than had been counted last week, and the Source: www.latimes.com FDA Advisory Committee Unanimously Recommends Approval of Ustekinumab - Forbes HORSHAM, Pa., June 17 /PRNewswire/ -- Centocor, Inc. announced today that the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) of the U.S. Food and Drug Administration (FDA) has unanimously recommended the approval of ustekinumab, a new Source: www.forbes.com FDA sends 25 warning letters for products falsely claiming to treat - Minneapolis Star Tribune WASHINGTON - The Food and Drug Administration is cracking down on teas, supplements, creams and other products that falsely claim to cure, treat or prevent cancer even though they are not agency-approved drugs. All are available for sale on the Source: www.startribune.com FDA Sends Warning Letters to 25 Companies Selling "Natural Cures for - ABC News Federal regulators are targeting more than two dozen companies they accuse of peddling "fake cures" and false hope to desperate cancer patients. (ABC News Photo Illustration) Officials with the Food and Drug Administration say these "online scammers Source: www.abcnews.go.com Allergan gets U.S. FDA approval for Trivaris eye infection drug - Forbes Allergan gets U.S. FDA approval for Trivaris eye infection drug - Forbes
LONDON (Thomson Financial) - Allergan Inc. said the U.S. Food and Drug Administration (FDA) has approved Trivaris (triamcinolone acetonide injectable suspension), a synthetic glucocorticoid corticosteroid with anti-inflammatory action. Delivered via Source: www.forbes.com 3rd UPDATE: Wyeth, Elan Alzheimer's Drug Effective In Some - CNN Money LONDON -(Dow Jones)- Pharma partners Wyeth (WYE) and Elan Corp. PLC (ELN) Tuesday said results from a highly anticipated mid-stage study of experimental Alzheimer's disease drug bapineuzumab show the treatment appears to be effective in some patients Source: money.cnn.com Deaths linked to blood thinner heparin increase to 149 - Chicago Tribune The blood thinner heparin has been linked to 149 U.S. deaths in people who had allergic reactions after taking it, U.S. regulators said. The new tally, posted Monday on the Food and Drug Administration's Web site, expands the toll of people who took Source: www.chicagotribune.com Cymbalta Approved for Fibromyalgia - Atlanta Journal Constitution MONDAY, June 16 (HealthDay News) -- Eli Lilly said Monday that its antidepressant Cymbalta (duloxetine) has been approved by the U.S. Food and Drug Administration to treat fibromyalgia, a chronic disorder with symptoms including widespread muscle Source: www.ajc.com Antipsychotics Will Display Drug Warning - Wall Street Journal The Food and Drug Administration said it will add so-called boxed warnings to the labels of older antipsychotic drugs, reflecting recent findings that the drugs could be dangerous for elderly people with dementia. Use of the drugs, which are designed Source: online.wsj.com Mylan Announces Tentative FDA Approval for Generic Version of - Forbes PITTSBURGH, June 16 /PRNewswire-FirstCall/ -- Mylan Inc. (NYSE: MYL) today announced that its subsidiary, Mylan Pharmaceuticals Inc., has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Source: www.forbes.com Mexican farmers angry over FDA salmonella probe - Los Angeles Times MEXICO CITY -- Farmers are mad enough to throw, well, rotten tomatoes at the U.S. Food and Drug Administration, which is focusing heavily on Mexico as a potential source of the fruit that has sickened hundreds of people in the United States with Source: www.latimes.com Ipca receives US FDA nod for nausea drug - Business Standard Drug maker Ipca Laboratories today said it has received US regulatory approval for marketing metoclopramide tablets used in the treatment of nausea. "Ipca has received US Food and Drug Administration approval to manufacture and market metoclopramide Source: www.business-standard.com Pharming to meet with European, U.S. regulators to speed Rhucin - Forbes AMSTERDAM (Thomson Financial) - Dutch biotech company Pharming Group NV said on Monday it will meet with the European Medicines Evaluation Agency (EMEA) and the U.S. Food and Drug Administration to accelerate regulatory filings in Europe and the U.S Source: www.forbes.com Mylan Announces Tentative FDA Approval for Generic Version of - Forbes Mylan Announces Tentative FDA Approval for Generic Version of - Forbes
PITTSBURGH, June 16 /PRNewswire-FirstCall/ -- Mylan Inc. (NYSE: MYL) today announced that its subsidiary, Mylan Pharmaceuticals Inc., has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Source: www.forbes.com FDA warns about fraudulent cancer treatments - Forbes The Food and Drug Administration is cracking down on teas, supplements, creams and other products that falsely claim to cure, treat or prevent cancer even though they are not agency-approved drugs. All are available for sale on the Internet. The Source: www.forbes.com UPDATE 1-US FDA warns Chattem over Icy Hot patches - Reuters WASHINGTON, June 17 (Reuters) - Chattem Inc (CHTT.O: Quote , Profile , Research , Stock Buzz ) failed to notify U.S. health officials about new cautions added to its Icy Hot heat therapy patches after getting more than 168 complaints, according to a Source: www.reuters.com FDA: Baja, Mexico, cleared in salmonella probe - USA Today WASHINGTON (AP) — One part of Mexico — Baja California — has been cleared of suspicion in the outbreak of salmonella-tainted tomatoes, which U.S. officials said Monday now has sickened 277 people. That's 49 more than had been counted last week Source: www.usatoday.com Amgen's Enbrel in kids "concerning": FDA staff - Reuters WASHINGTON (Reuters) - U.S. Food and Drug Administration reviewers are concerned about life-threatening complications in children taking Amgen Inc's drug Enbrel for psoriasis and other conditions, according to agency documents released on Monday Source: www.reuters.com FDA OKs Medtronic wire for heartbeat regulation - CNBC MINNEAPOLIS - Medical device maker Medtronic Inc. said Tuesday it received Food and Drug Administration approval to market a wire that delivers electrical pulses to the heart from a device that regulates heartbeat. The wire, called the Attain StarFix Source: www.cnbc.com Revolutions Medical Corporation Schedules Lab Testing for FDA 510K - MSN MoneyCentral Revolutions Medical Corporation RMCP has delivered 2000 of their proprietary Rev Vac 3cc Safety Syringes to be tested by SON Medical for its FDA 510K application. “ The lab testing is an integral part of the FDA process and we are very confident in Source: news.moneycentral.msn.com Medtronic gets FDA approval for Attain StarFix cardiac - CNBC Medtronic gets FDA approval for Attain StarFix cardiac - CNBC
BOSTON (Thomson Financial) - Medtronic Inc. Tuesday said it has received approval from the Food and Drug Administration for its Attain StarFix over-the-wire lead. Medtronic said Attain StarFix is the industry's first-ever active fixation left-heart Source: www.cnbc.com Mexican farmers angry over FDA salmonella probe - Los Angeles Times MEXICO CITY -- Farmers are mad enough to throw, well, rotten tomatoes at the U.S. Food and Drug Administration, which is focusing heavily on Mexico as a potential source of the fruit that has sickened hundreds of people in the United States with Source: www.latimes.com Mylan Announces Tentative FDA Approval for Generic Version of - Forbes PITTSBURGH, June 16 /PRNewswire-FirstCall/ -- Mylan Inc. (NYSE: MYL) today announced that its subsidiary, Mylan Pharmaceuticals Inc., has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Source: www.forbes.com Medtronic gets FDA approval for Attain StarFix cardiac - CNBC Medtronic gets FDA approval for Attain StarFix cardiac - CNBC
BOSTON (Thomson Financial) - Medtronic Inc. Tuesday said it has received approval from the Food and Drug Administration for its Attain StarFix over-the-wire lead. Medtronic said Attain StarFix is the industry's first-ever active fixation left-heart Source: www.cnbc.com Medtronic Receives FDA Approval of Industry's First Active Fixation - MSN MoneyCentral Medtronic, Inc. MDT today announced U.S. Food and Drug Administration (FDA) approval of the Medtronic Attain StarFix ® OTW (over-the-wire) lead (Model 4195). As the first-ever active fixation left-heart lead for cardiac resynchronization therapy Source: news.moneycentral.msn.com FDA OKs Medtronic wire for heartbeat regulation - MSN MoneyCentral MINNEAPOLIS (AP) - Medical device maker Medtronic Inc. said Tuesday it received Food and Drug Administration approval to market a wire that delivers electrical pulses to the heart from a device that regulates heartbeat. The wire, called the Attain Source: moneycentral.msn.com NeoMend Receives FDA Panel's Recommendation for Approval of ProGEL(TM - Forbes IRVINE, Calif., June 17 /PRNewswire/ -- NeoMend, Inc. today announced that its ProGEL(TM) Surgical Sealant has received a recommendation for approval from the U.S. Food and Drug Administration's (FDA) Anesthesiology and Respiratory Therapy Devices Source: www.forbes.com prasugrel: FDA set to weigh in, high chance for approval with label - Financial Times With the FDA set to finally weigh in on Eli Lilly and Daiichi Sankyo’s oral anticoagulant Effient (prasugrel), cardiologists say they are hopeful the drug will be approved and the bleeding risk found during clinical trials will be dealt with in the Source: www.ft.com FDA Clears Part of Mexico in Salmonella Tomato Probe - FOX News One part of Mexico — Baja California — has been cleared of suspicion in the outbreak of salmonella-tainted tomatoes, which U.S. officials said Monday now has sickened 277 people. That's 49 more than had been counted last week, and the latest Source: www.foxnews.com Mexican farmers angry over FDA salmonella probe - Los Angeles Times MEXICO CITY -- Farmers are mad enough to throw, well, rotten tomatoes at the U.S. Food and Drug Administration, which is focusing heavily on Mexico as a potential source of the fruit that has sickened hundreds of people in the United States with Source: www.latimes.com prasugrel: FDA set to weigh in, high chance for approval with label - Financial Times prasugrel: FDA set to weigh in, high chance for approval with label - Financial Times
With the FDA set to finally weigh in on Eli Lilly and Daiichi Sankyo’s oral anticoagulant Effient (prasugrel), cardiologists say they are hopeful the drug will be approved and the bleeding risk found during clinical trials will be dealt with in the Source: www.ft.com Medtronic gets FDA approval for Attain StarFix cardiac - CNBC BOSTON (Thomson Financial) - Medtronic Inc. Tuesday said it has received approval from the Food and Drug Administration for its Attain StarFix over-the-wire lead. Medtronic said Attain StarFix is the industry's first-ever active fixation left-heart Source: www.cnbc.com Mexican farmers angry over FDA salmonella probe - Los Angeles Times MEXICO CITY -- Farmers are mad enough to throw, well, rotten tomatoes at the U.S. Food and Drug Administration, which is focusing heavily on Mexico as a potential source of the fruit that has sickened hundreds of people in the United States with Source: www.latimes.com FDA: Baja, Mexico, cleared in salmonella probe - USA Today WASHINGTON (AP) — One part of Mexico — Baja California — has been cleared of suspicion in the outbreak of salmonella-tainted tomatoes, which U.S. officials said Monday now has sickened 277 people. That's 49 more than had been counted last week Source: www.usatoday.com Exelixis gets FDA nod for thyroid cancer drug trial - CNN Money NEW YORK (Associated Press) - Biopharmaceutical company Exelixis Inc. said Monday it reached an agreement with the Food and Drug Administration on the design of a late-stage trial for a drug to treat thyroid cancer. The agreement came through a Source: money.cnn.com Allergan wins FDA approval for retinal injection - Forbes Allergan Inc. late Monday said it received Food and Drug Administration approval for an injectable eye drug to treat retinal diseases. Trivaris, which is injected directly into the eye, is a steroid that reduces inflammation of the retina that can Source: www.forbes.com Pregnant Women to Benefit from Better Information Pregnant Women to Benefit from Better Information
A proposed rule will give women and their health care professionals better information concerning the effects of medications taken during pregnancy or while breastfeeding. Mommy's Bliss Nipple Cream Product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants. Calcilo XD Low-Calcium Vitamin D-Free Infant Formula With Iron Powder Product recalled because of possible oxidation that can cause gastrointestinal symptoms in infants. Current Drug Shortage: Levothyroxine sodium lyophilized powder for injection. Bedford has the 200 mcg vials (NDC 55390-0880-10) available. APP plans to have levothyroxine vials available again Start at the Store: 7 Ways to Prevent Foodborne Illness Food safety for consumers should begin at the supermarket or grocery store. Here are useful hints to keep in mind when shopping for food that will help keep foodborne illnesses out of your home. Morphine Sulfate 60 mg Extended Release Tablets Voluntarily recall of a single lot (No. 91762) due to a report of a tablet with twice the appropriate thickness. Drug to be Discontinued: Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension) Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension), Dear Healthcare Professional Letter available for more information. Sentinel System to Monitor Medical Product Safety FDA's new Sentinel Initiative aims to establish a national electronic system for tracking medical product performance. Cipher's revised NDA for CIP-TRAMADOL ER accepted for review by FDA - Earthtimes Cipher's revised NDA for CIP-TRAMADOL ER accepted for review by FDA - Earthtimes
Author : Cipher Pharmaceuticals Inc. MISSISSAUGA, ON , June 17 - Cipher Pharmaceuticals Inc. (TSX: DND) today announced that its revised New Drug Application (NDA) for CIP-TRAMADOL ER, its extended-release formulation of tramadol, has been accepted Source: www.earthtimes.org FDA: Baja, Mexico, cleared in salmonella probe - USA Today WASHINGTON (AP) — One part of Mexico — Baja California — has been cleared of suspicion in the outbreak of salmonella-tainted tomatoes, which U.S. officials said Monday now has sickened 277 people. That's 49 more than had been counted last week Source: www.usatoday.com FDA Cites Drugs' Risks For Elderly - Hartford Courant WASHINGTON — - The Food and Drug Administration warned doctors Monday that prescribing a certain group of psychiatric drugs to seniors with dementia can increase their risk of death. Antipsychotic drugs are approved to treat schizophrenia and Source: www.courant.com FDA: older psych drugs have fatal risks in seniors - Arizona Daily Star WASHINGTON — The Food and Drug Administration warned doctors Monday that prescribing a certain group of psychiatric drugs to seniors suffering from dementia can increase their risk of death. Antipsychotic drugs are approved to treat schizophrenia Source: www.azstarnet.com Some drugs risky for seniors, FDA says - Seattle Times WASHINGTON — The Food and Drug Administration warned doctors Monday that prescribing a certain group of psychiatric drugs to seniors suffering from dementia can increase their risk of death. Antipsychotic drugs are approved to treat schizophrenia Source: seattletimes.nwsource.com Mexican farmers angry over FDA salmonella probe - Los Angeles Times MEXICO CITY -- Farmers are mad enough to throw, well, rotten tomatoes at the U.S. Food and Drug Administration, which is focusing heavily on Mexico as a potential source of the fruit that has sickened hundreds of people in the United States with Source: www.latimes.com Hunt for source of salmonella-tainted tomatoes continues - Newsday As the search for the source of salmonella-tainted tomatoes dragged on, federal officials announced several more cases of infection Monday. The rare Salmonella Saintpaul strain has now caused 277 reported infections in 28 states and Washington, D.C Source: www.newsday.com Mexican farmers angry over FDA salmonella probe - Los Angeles Times Mexican farmers angry over FDA salmonella probe - Los Angeles Times
MEXICO CITY -- Farmers are mad enough to throw, well, rotten tomatoes at the U.S. Food and Drug Administration, which is focusing heavily on Mexico as a potential source of the fruit that has sickened hundreds of people in the United States with Source: www.latimes.com Mylan Announces Tentative FDA Approval for Generic Version of - Forbes PITTSBURGH, June 16 /PRNewswire-FirstCall/ -- Mylan Inc. (NYSE: MYL) today announced that its subsidiary, Mylan Pharmaceuticals Inc., has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Source: www.forbes.com Antipsychotics Will Display Drug Warning - Wall Street Journal The Food and Drug Administration said it will add so-called boxed warnings to the labels of older antipsychotic drugs, reflecting recent findings that the drugs could be dangerous for elderly people with dementia. Use of the drugs, which are designed Source: online.wsj.com Deaths linked to blood thinner heparin increase to 149 - Chicago Tribune The blood thinner heparin has been linked to 149 U.S. deaths in people who had allergic reactions after taking it, U.S. regulators said. The new tally, posted Monday on the Food and Drug Administration's Web site, expands the toll of people who took Source: www.chicagotribune.com Cymbalta Approved for Fibromyalgia - Atlanta Journal Constitution MONDAY, June 16 (HealthDay News) -- Eli Lilly said Monday that its antidepressant Cymbalta (duloxetine) has been approved by the U.S. Food and Drug Administration to treat fibromyalgia, a chronic disorder with symptoms including widespread muscle Source: www.ajc.com Pharming to meet with European, U.S. regulators to speed Rhucin - Forbes AMSTERDAM (Thomson Financial) - Dutch biotech company Pharming Group NV said on Monday it will meet with the European Medicines Evaluation Agency (EMEA) and the U.S. Food and Drug Administration to accelerate regulatory filings in Europe and the U.S Source: www.forbes.com 3rd UPDATE: Wyeth, Elan Alzheimer's Drug Effective In Some - CNN Money LONDON -(Dow Jones)- Pharma partners Wyeth (WYE) and Elan Corp. PLC (ELN) Tuesday said results from a highly anticipated mid-stage study of experimental Alzheimer's disease drug bapineuzumab show the treatment appears to be effective in some patients Source: money.cnn.com Allergan gets U.S. FDA approval for Trivaris eye infection drug - Forbes LONDON (Thomson Financial) - Allergan Inc. said the U.S. Food and Drug Administration (FDA) has approved Trivaris (triamcinolone acetonide injectable suspension), a synthetic glucocorticoid corticosteroid with anti-inflammatory action. Delivered via Source: www.forbes.com Ipca receives US FDA nod for nausea drug - Business Standard Drug maker Ipca Laboratories today said it has received US regulatory approval for marketing metoclopramide tablets used in the treatment of nausea. "Ipca has received US Food and Drug Administration approval to manufacture and market metoclopramide Source: www.business-standard.com U.S.: Older pills risky for seniors with dementia - Chicago Tribune WASHINGTON—The Food and Drug Administration warned doctors Monday that prescribing a certain group of psychiatric drugs to seniors suffering from dementia can increase their risk of death. Antipsychotic drugs are approved to treat schizophrenia and Source: www.chicagotribune.com Deaths linked to blood thinner heparin increase to 149 - Chicago Tribune Deaths linked to blood thinner heparin increase to 149 - Chicago Tribune
The blood thinner heparin has been linked to 149 U.S. deaths in people who had allergic reactions after taking it, U.S. regulators said. The new tally, posted Monday on the Food and Drug Administration's Web site, expands the toll of people who took Source: www.chicagotribune.com Cypress Bioscience up on Cymbalta approval - Forbes Shares of Cypress Bioscience Inc. surged Monday, as analysts said the Food and Drug Administration's approval of Eli Lilly & Co.'s antidepressant Cymbalta as a treatment for fibromyalgia bodes well for a similar Cypress drug. Shares of San Diego Source: www.forbes.com Psychiatric Drugs Can Carry Risk To Seniors, FDA Warns - Tampa Bay Online WASHINGTON - The Food and Drug Administration warned doctors Monday that prescribing a certain group of psychiatric drugs to seniors suffering from dementia can increase their risk of death. Antipsychotic drugs are approved to treat schizophrenia and Source: www2.tbo.com Atrium Initiates Voluntary Recall Action Regarding HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters used for Autotransfusion during Cardiopulmonary Bypass Surgery (May 12) Atrium Initiates Voluntary Recall Action Regarding HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters used for Autotransfusion during Cardiopulmonary Bypass Surgery (May 12)
Atrium Medical Corporation today announced that it is initiating a voluntary and precautionary recall of selected lots of HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters. Limited lots of Atrium heparin-coated Hydraglide Thoracic Catheters were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate. FDA Announces Limited Return of Heartworm Drug to U.S. Market ProHeart 6 Sustained Release Injectable for Dogs, manufactured by Fort Dodge Animal Health, is an approved injectable sustained-release heartworm prevention product for dogs. FDA is concurring with its limited return, to the U.S. veterinary market under a risk minimization and restricted distribution program designed to manage the re-introduction of ProHeart 6 to provide for safe, appropriate use of the product while minimizing risk to dogs. International Pharmaceuticals, Ltd. Issues a Voluntary Recall of all Viril-Ity-Power (VIP) Tabs, a Product Marketed as a Dietary Supplement (May 29) International Pharmaceuticals, Ltd., announced that it is conducting a voluntary recall of all the company’s supplement product sold under the brand name of Viril-Ity-Power (VIP) Tabs, 560mg/serving. Xiadafil VIP Tablets Consumers advised not to purchase or use the product, marketed as a dietary supplement, because it contains a potentially harmful, undeclared ingredient that may dangerously affect a person's blood pressure and can cause other life-threatening side effects. FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs The U.S. Food and Drug Administration today exercised its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to require manufacturers of "conventional" antipsychotic drugs to make safety-related changes to prescribing information, or labeling, to warn about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia. June 16, 2008FDA Requests Recall of Xiadafil VIP Tabs FDA Requests Recall of Xiadafil VIP Tabs
The U.S. Food and Drug Administration today requested that SEI Pharmaceuticals, of Miami, Fla., recall all Xiadafil VIP Tabs sold in 8 tablet bottles (Lot # 6K029) or blister cards of 2 tablets (Lot # 6K029-SEI) because these products contain a potentially harmful, undeclared ingredient that may dangerously affect a person's blood pressure and can cause other life-threatening side effects. Current Drug Shortage: Levothyroxine sodium lyophilized powder for injection. Bedford has the 200 mcg vials (NDC 55390-0880-10) available. APP plans to have levothyroxine vials available again June 2008 Patient Safety News Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. Drug to be Discontinued: Intal Nebulizer Solution (cromolyn sodium inhalation solution, USP) Intal Nebulizer Solution (cromolyn sodium inhalation solution, USP. Dear Healthcare Professional Letter is available for more information. Spring 2008 Drug Safety Newsletter DSN provides information for healthcare professionals and the medical community about findings of selected post-marketing drug safety reviews, important emerging drug safety issues, and recently approved new molecular entities. Drug to be Discontinued: Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension) Drug to be Discontinued: Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension)
Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension), Dear Healthcare Professional Letter available for more information. Orval Kent Foods Recalls Single Limited Production Run of Amish Macaroni Salad Sold Under the Orval Kent and Yoder’s Brand Names (May 28) Orval Kent Foods is voluntarily recalling approximately 23,000 pounds of Amish Macaroni Salad that may pose a health risk. This voluntary action is being taken in response to the results of a test conducted on a single package of Amish Macaroni Salad by the Ohio Department of Agriculture and Consumer Services, Division of Food Safety, for E. coli O157:H7. Blount Fine Foods Issues Allergy Alert On Undeclared Shrimp in All Natural New England Clam Chowder, 20 Oz Cup (May 6) Blount Fine Foods is recalling Blount All Natural New England Clam Chowder, Net Wt. 20 oz with Lot: 0424086D, Sell by date: 6/23/2008, because it may contain undeclared shrimp. People who have an allergy or severe sensitivity to shrimp run the risk of serious or life-threatening allergic reaction if they consume these products. The firm has recovered 1,400 of 1,416 units produced, 16 units are in distribution. Medtronic Initiates Voluntary Field Actions for Selected Heparin-Coated Products Used During Cardiopulmonary Bypass (May 7) Medtronic, Inc. announced that it is initiating a voluntary and precautionary recall of selected products featuring the Carmeda BioActive surface. The affected devices are disposable products used during cardiopulmonary bypass (CPB) for heart surgeries. Affected products include blood oxygenators, reservoirs, pumps, cannulae, and tubing packs. FDA Warns Consumers in New Mexico and Texas Not to Eat Certain Types of Raw Red Tomatoes The Food and Drug Administration is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes. The bacteria causing the illnesses are Salmonella serotype Saintpaul, an uncommon type of Salmonella. Drug Shortage: Digitek (digoxin tablets, USP) Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.) recalled of all lots of Bertek and UDL Laboratories Digitek (digoxin tablets, USP). Other manufacturers of digoxin tablets are available and listed on the Drug Shortage website. Start at the Store: 7 Ways to Prevent Foodborne Illness Food safety for consumers should begin at the supermarket or grocery store. Here are useful hints to keep in mind when shopping for food that will help keep foodborne illnesses out of your home. Sentinel System to Monitor Medical Product Safety FDA's new Sentinel Initiative aims to establish a national electronic system for tracking medical product performance. Lake Country Lamb Feed Voluntary Recall (June 6) The Land O'Lakes Purina Feed plant in Fremont, Neb., has initiated a limited voluntary recall of two lamb feed products due to higher than acceptable levels of copper. Supreme Cuts Announces Voluntary Recall of Small Sample of Off The Cob Fresh Kernel Corn (May 27) As a precautionary measure, Supreme Cuts LLC has announced that it is voluntarily recalling 87 cases of Off the Cob Fresh Kernel Corn in 12 oz bags. The product may be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail and elderly people, and others with weakened immune systems. Drug to be Discontinued: Intal Nebulizer Solution (cromolyn sodium inhalation solution, USP) Drug to be Discontinued: Intal Nebulizer Solution (cromolyn sodium inhalation solution, USP)
Intal Nebulizer Solution (cromolyn sodium inhalation solution, USP. Dear Healthcare Professional Letter is available for more information. Regranex (becaplermin) Gel Product given a Boxed Warning about an increased risk of death from cancer in patients using three or more tubes of Regranex. FDA Safety Update: Asthma Medications May is Asthma and Allergy Awareness Month. Here is a roundup of recent safety issues related to asthma medications. Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial Drug to be Discontinued: Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension) Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension), Dear Healthcare Professional Letter available for more information. U.S. FDA expands antipsychotic drug warning - Guardian Unlimited U.S. FDA expands antipsychotic drug warning - Guardian Unlimited
WASHINGTON, June 16 (Reuters) - Older, conventional antipsychotic medications can increase the risk of death in some elderly patients, the U.S. Food and Drug Administration warned on Monday. The agency called for the drugs to include a strong "black Source: www.guardian.co.uk Exelixis shares up on thyroid cancer deal with FDA - CNN Money NEW YORK (Associated Press) - Shares of Exelixis Inc. rose Monday, after the biopharmaceutical company reached an agreement with the Food and Drug Administration on the design of a late-stage trial for its drug XL184 as a treatment for thyroid cancer Source: money.cnn.com Amgen's Enbrel Causes Side Effects in Kids, FDA Says (Update3) - Bloomberg June 16 (Bloomberg) -- Amgen Inc. 's anti-inflammatory medication Enbrel causes ``life-threatening'' side effects in children with psoriasis, U.S. regulators said in a report that cast doubt about whether the drug can win expanded approval. Enbrel Source: www.bloomberg.com UPDATE 1-U.S. FDA expands antipsychotic drug warning - Reuters WASHINGTON, June 16 (Reuters) - Older, conventional antipsychotic medications can increase the risk of death in some elderly patients, the U.S. Food and Drug Administration warned on Monday. The agency called for the drugs to include a strong "black Source: www.reuters.com FDA Expands Antipsychotic Drug Warning - ABC News WASHINGTON (Reuters) - Older, conventional antipsychotic medications can increase the risk of death in some elderly patients, the U.S. Food and Drug Administration warned on Monday. The agency called for the drugs to include a strong "black box Source: www.abcnews.go.com Mylan gets final FDA OK for generic antidepressant - CNN Money NEW YORK (Associated Press) - Drug developer Mylan Inc. said Monday the Food and Drug Administration granted final approval for the generic version of Wyeth's antidepressant Effexor. Mylan said it will begin shipping its version of the drug Source: money.cnn.com Mylan Announces Tentative FDA Approval for Generic Version of - Forbes PITTSBURGH, June 16 /PRNewswire-FirstCall/ -- Mylan Inc. (NYSE: MYL) today announced that its subsidiary, Mylan Pharmaceuticals Inc., has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Source: www.forbes.com Cardinal Alcohol-Free Mouthwash Cardinal Alcohol-Free Mouthwash
Additional lot recalled because of the presence of Burkholderia cepacia. Solodyn (minocycline HCL) Extended Release Tablets 90 mg Recall of certain lots because one bottle of Solodyn contained Azasan (azathioprine). Why it takes so long to trace a bad tomato - MSNBC Why it takes so long to trace a bad tomato - MSNBC
WASHINGTON - Food and Drug Administration detectives had a hot lead, narrowing down on a grower who just might have supplied salmonella-tainted tomatoes. Then the patient changed her story: She'd eaten a round tomato, not a Roma one after all. "We Source: www.msnbc.msn.com Risk-averse investors threaten drug development - The Independent New drug development by the biotechnology industry is threatened by increasingly risk-averse investors and intensifying competition from generic rivals, a survey shows. A major cause of investor wariness is the growing caution of the US Food and Drug Source: www.independent.co.uk Psoriasis Drug Appears Effective But May Increase Cancer Risk - Wall Street Journal WASHINGTON -- The Food and Drug Administration on Friday said a drug from a Johnson & Johnson unit appears effective at treating a severe skin disease, but warned it may increase the risk of cancer. The FDA said it may Source: online.wsj.com Tracing Roots of Tainted Tomatoes is Very Difficult - Redorbit.com Food and Drug Administration detectives had a hot lead, narrowing down on a grower who just might have supplied salmonella-tainted tomatoes. Then the patient changed her story: She'd eaten a round tomato, not a Roma one after all. "We basically had Source: www.redorbit.com FDA generic drug reviews delayed, report finds - Reuters WASHINGTON (Reuters) - The U.S. Food and Drug Administration failed to review on time nearly half the applications from generic drug makers seeking approval to sell cheaper versions of brand-name pharmaceuticals, according to a government report Source: www.reuters.com FDA generic drug reviews delayed, report finds - Reuters FDA generic drug reviews delayed, report finds - Reuters
WASHINGTON (Reuters) - The U.S. Food and Drug Administration failed to review on time nearly half the applications from generic drug makers seeking approval to sell cheaper versions of brand-name pharmaceuticals, according to a government report Source: www.reuters.com Do your tomatoes have salmonella? - Sheknows.com Michele Thompson, MS What started as a two-state warning about contaminated raw red tomatoes on June 3rd has now spread nationwide. According to the Food and Drug Administration (FDA) about 150 people in 16 states have been sickened by a rare strain Source: www.sheknows.com Psoriasis Drug Appears Effective But May Increase Cancer Risk - Wall Street Journal WASHINGTON -- The Food and Drug Administration on Friday said a drug from a Johnson & Johnson unit appears effective at treating a severe skin disease, but warned it may increase the risk of cancer. The FDA said it may Source: online.wsj.com FDA: Mexico, Florida Suspects in Salmonella Outbreak - FOX News FDA: Mexico, Florida Suspects in Salmonella Outbreak - FOX News
But the FDA hasn't narrowed its hunt to just those two places, said Dr. David Acheson, the agency's food safety chief. "The logical assumption would be that Florida or Mexico are the most likely source" because of the outbreak's timing, he told The Source: www.foxnews.com Sensitivity Enhancements to Monogram's Trofile(TM) Assay Demonstrate - MSN MoneyCentral SOUTH SAN FRANCISCO, Calif., June 16 /PRNewswire-FirstCall/ -- Monogram Biosciences, Inc. MGRM today announced that data related to the enhanced performance of the company's HIV tropism assay were presented in an oral presentation at the 17th Source: news.moneycentral.msn.com FDA backs new tests to monitor drug safety - San Francisco Gate FDA backs new tests to monitor drug safety - San Francisco Gate
del.icio.us Drug regulators in the United States and Europe are encouraging pharmaceutical companies to use a set of sensitive new tests that can pick up early signs that an experimental medicine might cause kidney damage. The joint endorsement Source: www.sfgate.com FDA: Fla., Mexico suspects in tomato outbreak - Chicago Sun-Times WASHINGTON---- Parts of Florida and Mexico were supplying ''the vast majority'' of tomatoes sold when the salmonella outbreak began in April and thus remain leading suspects, the Food and Drug Administration said Friday. But the FDA hasn't narrowed Source: www.suntimes.com International Pharmaceuticals, Ltd. Issues a Voluntary Recall of all Viril-Ity-Power (VIP) Tabs, a Product Marketed as a Dietary Supplement (May 29) International Pharmaceuticals, Ltd. Issues a Voluntary Recall of all Viril-Ity-Power (VIP) Tabs, a Product Marketed as a Dietary Supplement (May 29)
International Pharmaceuticals, Ltd., announced that it is conducting a voluntary recall of all the company’s supplement product sold under the brand name of Viril-Ity-Power (VIP) Tabs, 560mg/serving. Sweetwater Valley Farm, Inc. Recalls Tennessee Aged Black Pepper Cheese (May 15) Sweetwater Valley Farm, Inc. is recalling Tennessee Aged Black Pepper Cheese because it has the potential to be contaminated with Listeria monocytogenes. The cheese, Lot Number 616-361 was distributed in 5, 7, and 10 ounce bars through our retail store in Philadelphia, TN and a Winery in Portland, TN. June 15, 2008Blount Fine Foods Issues Allergy Alert On Undeclared Shrimp in All Natural New England Clam Chowder, 20 Oz Cup (May 6) Blount Fine Foods Issues Allergy Alert On Undeclared Shrimp in All Natural New England Clam Chowder, 20 Oz Cup (May 6)
Blount Fine Foods is recalling Blount All Natural New England Clam Chowder, Net Wt. 20 oz with Lot: 0424086D, Sell by date: 6/23/2008, because it may contain undeclared shrimp. People who have an allergy or severe sensitivity to shrimp run the risk of serious or life-threatening allergic reaction if they consume these products. The firm has recovered 1,400 of 1,416 units produced, 16 units are in distribution. Drug to be Discontinued: Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP) Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP), Dear Healthcare Professional Letter available for more information. ETHEX Corporation Voluntarily Recalls Specific Lots of 30 mg. and 60 mg. Morphine Sulfate Extended Release Tablets Due to the Potential for Oversized Tablets (June 13) ETHEX Corporation announced today that it has voluntarily recalled specific additional lots of morphine sulfate 60 mg extended release tablets, and specific lots of morphine sulfate 30 mg extended release tablets, as a precaution, due to the possible presence of oversized tablets. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate. The recalled lots were distributed by ETHEX Corporation under an "ETHEX" label between June 2006 and May 2008. Blount Fine Foods Issues Allergy Alert On Undeclared Shrimp in All Natural New England Clam Chowder, 20 Oz Cup (May 6) Blount Fine Foods Issues Allergy Alert On Undeclared Shrimp in All Natural New England Clam Chowder, 20 Oz Cup (May 6)
Blount Fine Foods is recalling Blount All Natural New England Clam Chowder, Net Wt. 20 oz with Lot: 0424086D, Sell by date: 6/23/2008, because it may contain undeclared shrimp. People who have an allergy or severe sensitivity to shrimp run the risk of serious or life-threatening allergic reaction if they consume these products. The firm has recovered 1,400 of 1,416 units produced, 16 units are in distribution. Atrium Initiates Voluntary Recall Action Regarding HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters used for Autotransfusion during Cardiopulmonary Bypass Surgery (May 12) Atrium Medical Corporation today announced that it is initiating a voluntary and precautionary recall of selected lots of HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters. Limited lots of Atrium heparin-coated Hydraglide Thoracic Catheters were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate. Drug to be Discontinued: Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP) Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP), Dear Healthcare Professional Letter available for more information. Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial
Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial Recalls and Safety Alerts: FDA Studying Potential Safety Issues with Several Drugs FDA has informed the health care community about ongoing safety reviews of several drugs. FDA is doing this as part of its commitment to inform health care professionals and the public about its ongoing drug safety reviews. Because this information... Current Drug Shortage: Levothyroxine sodium lyophilized powder for injection. Bedford has the 200 mcg vials (NDC 55390-0880-10) available. APP plans to have levothyroxine vials available again Why it takes so long to trace a bad tomato - MSNBC Why it takes so long to trace a bad tomato - MSNBC
WASHINGTON - Food and Drug Administration detectives had a hot lead, narrowing down on a grower who just might have supplied salmonella-tainted tomatoes. Then the patient changed her story: She'd eaten a round tomato, not a Roma one after all. "We Source: www.msnbc.msn.com Tracing Roots of Tainted Tomatoes is Very Difficult - Redorbit.com Food and Drug Administration detectives had a hot lead, narrowing down on a grower who just might have supplied salmonella-tainted tomatoes. Then the patient changed her story: She'd eaten a round tomato, not a Roma one after all. "We basically had Source: www.redorbit.com TOMATOES AND SALMONELLA - Houston Chronicle WASHINGTON — Parts of Florida and Mexico were supplying "the vast majority" of tomatoes sold when the salmonella outbreak began in April and thus remain leading suspects, the Food and Drug Administration said Friday. But the FDA hasn't narrowed its Source: www.chron.com Risk-averse investors threaten drug development - The Independent New drug development by the biotechnology industry is threatened by increasingly risk-averse investors and intensifying competition from generic rivals, a survey shows. A major cause of investor wariness is the growing caution of the US Food and Drug Source: www.independent.co.uk Shire's shares could fall even more - Barron's - Reuters NEW YORK, June 15 (Reuters) - Although Shire's (SHP.L: Quote , Profile , Research , Stock Buzz ) American depositary shares (SHPGY.O: Quote , Profile , Research , Stock Buzz ) have dropped, they could fall another 15 percent to 20 percent if the Source: www.reuters.com Drug cuts risk of prostate cancer by 30%, study shows - International Herald Tribune Drug cuts risk of prostate cancer by 30%, study shows - International Herald Tribune
For the first time, leading prostate cancer specialists say they have a drug that can significantly cut men's risk of developing the disease, dropping the incidence by 30 percent. But the discovery, arising from a new analysis of a large federal Source: www.iht.com FDA may require cancer-risk labeling on J&J drug - Philadelphia Inquirer WASHINGTON - An experimental drug from a unit of Johnson & Johnson appears effective at treating a severe skin disease, though government regulators said Friday it also could slightly increase cancer risks. Centocor has asked the Food and Drug Source: www.philly.com FDA: JNJ Unit's Psoriasis Drug Appears Effective - CNN Money WASHINGTON -(Dow Jones)- The Food and Drug Administration on Friday said a drug from a Johnson & Johnson (JNJ) unit appears effective at treating a severe skin disease, but warned it may increase the risk of cancer. The FDA said it may need more long Source: money.cnn.com Finding bad tomatoes a whodunnit - Texarkana Gazette WASHINGTON—Food and Drug Administration detectives had a hot lead, narrowing down on a grower who just might have supplied salmonella-tainted tomatoes. Then the patient changed her story: She’d eaten a round tomato, not a Roma one after all Source: www.texarkanagazette.com FDA may require cancer-risk labeling on J&J drug - Forbes An experimental drug from a unit of Johnson & Johnson appears effective at treating a severe skin disease, though government regulators said Friday it also could slightly increase cancer risks. Centocor has asked the Food and Drug Administration to Source: www.forbes.com Settling suit, FDA issues precaution on silver dental fillings - Chicago Tribune WASHINGTON — Silver dental fillings contain mercury, and the government for the first time is warning that they may pose a safety concern for pregnant women and young children. The Food and Drug Administration posted the precaution on its Web site Source: www.chicagotribune.com Study is key for approval of first drug for female sexual dysfunction - Science Centric Study is key for approval of first drug for female sexual dysfunction - Science Centric
Women are being recruited to participate in a new multicentre study of the safety of testosterone gel for postmenopausal women with low sexual desire. The study design and goals will be presented at The Endocrine Society's 90th Annual Meeting in San Source: www.sciencecentric.com FDA: JNJ Unit's Psoriasis Drug Appears Effective - CNN Money WASHINGTON -(Dow Jones)- The Food and Drug Administration on Friday said a drug from a Johnson & Johnson (JNJ) unit appears effective at treating a severe skin disease, but warned it may increase the risk of cancer. The FDA said it may need more long Source: money.cnn.com US FDA generic drug reviews delayed, report finds - Forbes WASHINGTON (Reuters) - The Food and Drug Administration failed to review on time nearly half the applications from generic drug makers seeking approval to sell cheaper versions of brand-name pharmaceuticals, according to a government report released Source: www.forbes.com Settling suit, FDA issues precaution on silver dental fillings - Chicago Tribune WASHINGTON — Silver dental fillings contain mercury, and the government for the first time is warning that they may pose a safety concern for pregnant women and young children. The Food and Drug Administration posted the precaution on its Web site Source: www.chicagotribune.com Drug cuts risk of prostate cancer by 30%, study shows - International Herald Tribune For the first time, leading prostate cancer specialists say they have a drug that can significantly cut men's risk of developing the disease, dropping the incidence by 30 percent. But the discovery, arising from a new analysis of a large federal Source: www.iht.com FDA may require cancer-risk labeling on J&J drug - Philadelphia Inquirer WASHINGTON - An experimental drug from a unit of Johnson & Johnson appears effective at treating a severe skin disease, though government regulators said Friday it also could slightly increase cancer risks. Centocor has asked the Food and Drug Source: www.philly.com FDA may require cancer-risk labeling on J&J drug - Forbes An experimental drug from a unit of Johnson & Johnson appears effective at treating a severe skin disease, though government regulators said Friday it also could slightly increase cancer risks. Centocor has asked the Food and Drug Administration to Source: www.forbes.com Silver's risky for some smiles, FDA says - San Francisco Gate Silver's risky for some smiles, FDA says - San Francisco Gate
Silver dental fillings contain mercury, and the government is warning for the first time that they may pose a health concern for pregnant women and young children. The Food and Drug Administration posted the precaution on its Web site this month to Source: www.sfgate.com FDA: Florida, Mexico suspects in tomato outbreak - Salon Jun 13th, 2008 | WASHINGTON -- Parts of Florida and Mexico were supplying "the vast majority" of tomatoes sold when the salmonella outbreak began in April and thus remain leading suspects, the Food and Drug Administration said Friday. But the FDA Source: www.salon.com Sweetwater Valley Farm, Inc. Recalls Tennessee Aged Black Pepper Cheese (May 15) Sweetwater Valley Farm, Inc. Recalls Tennessee Aged Black Pepper Cheese (May 15)
Sweetwater Valley Farm, Inc. is recalling Tennessee Aged Black Pepper Cheese because it has the potential to be contaminated with Listeria monocytogenes. The cheese, Lot Number 616-361 was distributed in 5, 7, and 10 ounce bars through our retail store in Philadelphia, TN and a Winery in Portland, TN. Your Guide to Reporting Problems to FDA Your Guide to Reporting Problems to FDA
This guide provides tips and a quick-reference chart to help you report a problem to FDA. FDA Advises Patients to Switch to HFA-Propelled Albuterol Inhalers Now CFC-propelled albuterol inhalers are being phased out because they are harmful to the environment by contributing to depletion of the ozone layer above the Earth's surface. FDA Warns Consumers Against Using Mommy's Bliss Nipple Cream The U.S. Food and Drug Administration is warning consumers not to use or purchase Mommy's Bliss Nipple Cream, marketed by MOM Enterprises, Inc., because the product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants. FDA 101: How to Use the Consumer Complaint System and MedWatch When you have a problem with a food, drug, or other FDA-regulated product, FDA wants to hear from you. Here's how to report problems using two of FDA's main reporting systems. Mommy's Bliss Nipple Cream Product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants. FDA Warns Consumers in New Mexico and Texas Not to Eat Certain Types of Raw Red Tomatoes The Food and Drug Administration is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes. The bacteria causing the illnesses are Salmonella serotype Saintpaul, an uncommon type of Salmonella. |
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