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. |
