July 5, 2008Recall of Nestle Pure Life Purified Water (June 24) Recall of Nestle Pure Life Purified Water (June 24)
This announces a product recall for the one-gallon Nestle Pure Life Purified Drinking Water sold ONLY in Shop-Rite stores in the five Northeast states of Connecticut, Delaware, New Jersey, New York and Pennsylvania. This affects ONLY the one-gallon size. Giant Food Alerts Customers to Voluntary Recall of Giant Brand Garlic Bread and Garlic Spread (June 27) Giant Food has announced a voluntary recall of Giant brand garlic bread and garlic spread products sold in its Bakeshop as the items contain milk products which are not declared on the labels. Giant removed from its shelves all 16 ounce packages of Giant brand garlic bread and all 16 ounce packages of Giant brand garlic spread products. Bay Valley Foods Issues Allergy Alert on Undeclared Milk in Mislabeled Kroger Chicken Noodle Soup (June 24) The recalled product, Kroger Chicken Noodle Soup, comes in 10.5 ounce cans and is marked with lot code 52104098, and a "best before" date code of 40910 (April 9, 2010) that can be found on the bottom of the can. Consumers are urged to return the product to the store where it was purchased for a full refund. 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. 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. Drug to be Discontinued: Kemadrin (procyclidine hydrochloride) Kemadrin (procyclidine hydrochloride), Dear Healthcare Professional Letter available for 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. FDA: Diabetes Drugs Should Face Tougher Standards - FOX News FDA: Diabetes Drugs Should Face Tougher Standards - FOX News
Diabetes drugs should face tougher safety standards that could cost manufacturers millions but protect patients from unforeseen heart risks, a government panel has recommended. Advisers to the Food and Drug Administration voted 14-2 on Wednesday that Source: www.foxnews.com FDA must require tracking of produce: food groups - Reuters WASHINGTON (Reuters) - As more Americans get sick while health officials look for the cause of a salmonella outbreak sweeping the country, consumer groups said on Thursday the Food and Drug Administration must put emergency rules in place to track Source: www.reuters.com Sector Snap: Diabetes drug developers - Boston Globe NEW YORK— Proposals for tougher heart-risk studies on new Type 2 diabetes drugs weighed heavy on shares of Amylin Pharmaceuticals Inc. and Novo Nordisk AS Thursday, since stricter regulations could mean longer, more costly clinical trials. On Source: www.boston.com Inspectors study farms in Mexico, US, but no progress in salmonella - CNEWS Inspectors study farms in Mexico, US, but no progress in salmonella - CNEWS
AUTLAN, Mexico - Inspectors are collecting soil, water and produce samples, reviewing export logs and combing packing plants in three major tomato-growing states in Mexico. However, the U.S. Food and Drug Administration appears no closer to finding Source: cnews.canoe.ca FDA backs Abbott stent - Chicago Tribune While U.S. approval of Abbott Laboratories ' drug-coated heart stent is a boost to the North Chicago medical giant, the product enters a market that is shrinking as doctors rethink the role of artery-clearing devices in the prevention of heart Source: www.chicagotribune.com Diabetes meds need safety check, FDA is told - Fort Lauderdale Sun-Sentinel WASHINGTON - Diabetes drugs should face tougher safety standards that could cost manufacturers millions but protect patients from unforeseen heart risks, a government panel has recommended. Advisers to the Food and Drug Administration voted 14-2 on Source: www.sun-sentinel.com FDA must require tracking of produce - food groups - Forbes WASHINGTON (Reuters) - As more Americans get sick while health officials look for the cause of a salmonella outbreak sweeping the country, consumer groups said on Thursday the Food and Drug Administration must put emergency rules in place to track Source: www.forbes.com Mylan gets FDA OK to market generic antibiotic - CNN Money Mylan gets FDA OK to market generic antibiotic - CNN Money
NEW YORK (Associated Press) - Generic drug maker Mylan Inc. said Thursday it received tentative approval from the Food and Drug Administration to market its 600 milligram linezolid tablets. The antibiotic is a generic version of Pharmacia and Upjohn Source: money.cnn.com Adolor: FDA lifts clinical hold on Entereg program - CNBC BOSTON (Thomson Financial) - Adolor Corp. Thursday said the Food and Drug Administration has lifted the clinical hold on its new drug application for the Entereg program for chronic opioid bowel dysfunction. The Entereg program is currently under Source: www.cnbc.com New Drug-Coated Stent Approved - Washington Post New Drug-Coated Stent Approved - Washington Post
Resize Text THURSDAY, July 3 (HealthDay News) -- The Xience drug-coated stent, used to prop open a blocked or narrowed artery in people with coronary artery disease, has been approved by the U.S. Food and Drug Administration, maker Abbott Source: www.washingtonpost.com FDA reports more salmonella illnesses - Chicago Tribune WASHINGTON - The government on Saturday increased the number of people reported being sickened in a record salmonella outbreak in which tomatoes are the leading suspect although investigators are testing other types of fresh produce. There have been Source: www.chicagotribune.com FDA lifts clinical hold on Adolor bowel drug - CNBC EXTON, Pa. - Adolor Corp. said Thursday the Food and Drug Administration has lifted its clinical hold on the company's Entereg drug in chronically constipated patients taking opioid pain drugs. The drug is being developed in partnership with Source: www.cnbc.com FDA reports more cases of salmonella illnesses - Guardian Unlimited WASHINGTON (AP) - The government on Saturday increased the number of people reported being sickened in a record salmonella outbreak in which tomatoes are the leading suspect although investigators are testing other types of fresh produce. There have Source: www.guardian.co.uk Tainted Tomatoes: Another Salmonella Case In Tennessee - TriCities.com That brings the total number of cases in Tennessee to 7. None of the cases reported were in the Northeast Tennessee region. The latest case involves a Davidson County resident. Doctors believe the patient became ill in early June. The federal Food Source: www.tricities.com FDA must require tracking of produce: food groups - Reuters FDA must require tracking of produce: food groups - Reuters
WASHINGTON (Reuters) - As more Americans get sick while health officials look for the cause of a salmonella outbreak sweeping the country, consumer groups said on Thursday the Food and Drug Administration must put emergency rules in place to track Source: www.reuters.com FDA panel urges more testing for diabetes drugs - Kansas City Star Diabetes drugs should face tougher safety standards that could cost manufacturers millions but protect patients from unforeseen heart risks, a government panel has recommended. Advisers to the Food and Drug Administration voted 14-2 on Wednesday that Source: www.kansascity.com FDA lifts clinical hold on Adolor bowel drug - CNN Money NEW YORK (Associated Press) - Adolor Corp. said Thursday the Food and Drug Administration has lifted its clinical hold on the company's Entereg drug in chronically constipated patients taking opioid pain drugs. The drug is being developed in Source: money.cnn.com Mylan gets FDA OK to market generic antibiotic - CNN Money NEW YORK (Associated Press) - Generic drug maker Mylan Inc. said Thursday it received tentative approval from the Food and Drug Administration to market its 600 milligram linezolid tablets. The antibiotic is a generic version of Pharmacia and Upjohn Source: money.cnn.com Adolor: FDA lifts clinical hold on Entereg program - CNBC BOSTON (Thomson Financial) - Adolor Corp. Thursday said the Food and Drug Administration has lifted the clinical hold on its new drug application for the Entereg program for chronic opioid bowel dysfunction. The Entereg program is currently under Source: www.cnbc.com Radiology-centers chain is in default, FDA says - Baltimore Sun A regional chain of radiology centers and its owner are in default on $1.1 million in fines for performing mammograms after one of its facilities lost its certification to perform the procedure because of equipment problems, according to documents Source: www.baltimoresun.com How to stop superbugs - Boston Globe FOR ALL the breakthroughs medicine has achieved in treating cancer and heart disease, none has saved as many lives as the last century's discovery of antibiotics to treat infectious diseases. That is why physicians are so concerned about the Source: www.boston.com FDA lifts clinical hold on Adolor bowel drug - MSN MoneyCentral FDA lifts clinical hold on Adolor bowel drug - MSN MoneyCentral
EXTON, Pa. (AP) - Adolor Corp. said Thursday the Food and Drug Administration has lifted its clinical hold on the company's Entereg drug in chronically constipated patients taking opioid pain drugs. The drug is being developed in partnership with Source: moneycentral.msn.com FDA must require tracking of produce: food groups - Reuters WASHINGTON (Reuters) - As more Americans get sick while health officials look for the cause of a salmonella outbreak sweeping the country, consumer groups said on Thursday the Food and Drug Administration must put emergency rules in place to track Source: www.reuters.com FDA lifts clinical hold on Adolor bowel drug - CNBC EXTON, Pa. - Adolor Corp. said Thursday the Food and Drug Administration has lifted its clinical hold on the company's Entereg drug in chronically constipated patients taking opioid pain drugs. The drug is being developed in partnership with Source: www.cnbc.com U.S. Consumer Product Safety Commission News Stories and Articles - Atlanta Journal Constitution Daily Briefing: AUTOMOTIVE: June sales likely to be down sharply Detroit —- Toyota Motor Corp. could overtake General Motors Corp. in monthly U.S. sales for the first time in June, but the victory could be hollow as the weak economy continues to Source: www.ajc.com Wyeth, Progenics get European constipation drug OK - Forbes Drug developers Wyeth and Progenics Pharmaceuticals Inc. said Thursday European regulators approved Relistor as a treatment for constipation related to pain drugs taken by terminally ill patients. The injectable drug relieves opioid-induced Source: www.forbes.com Diabetes-drug testing pushed - Philadelphia Daily News WASHINGTON - Diabetes drugs should face tougher safety standards that could cost manufacturers millions, but protect patients from unforeseen heart risks, a government panel recommended. The Food and Drug Administration advisory panel voted, 14-2 Source: www.philly.com Shire buying German drug company - Philadelphia Inquirer Shire Ltd. will be acquiring German drug developer Jerini AG, which produces a treatment for a potentially fatal swelling of tissues and organs, for about $554 million. Shire, the U.K.'s third-biggest drugmaker, which has about 750 employees at the Source: www.philly.com Sector Snap: Diabetes drug developers - Forbes Proposals for tougher heart-risk studies on new Type 2 diabetes drugs weighed heavy on shares of Amylin Pharmaceuticals Inc. and Novo Nordisk AS Thursday, since stricter regulations could mean longer, more costly clinical trials. On Wednesday Source: www.forbes.com Tainted Tomatoes: Another Salmonella Case In Tennessee - TriCities.com That brings the total number of cases in Tennessee to 7. None of the cases reported were in the Northeast Tennessee region. The latest case involves a Davidson County resident. Doctors believe the patient became ill in early June. The federal Food Source: www.tricities.com Radiology-centers chain is in default, FDA says - Baltimore Sun Radiology-centers chain is in default, FDA says - Baltimore Sun
A regional chain of radiology centers and its owner are in default on $1.1 million in fines for performing mammograms after one of its facilities lost its certification to perform the procedure because of equipment problems, according to documents Source: www.baltimoresun.com FDA warns farms on antibiotic use - Newsday Inspectors found a common antibiotic has been misused in animals through practices such as injections into chicken eggs and ordered farmers to stop the unapproved treatments because of the risk to humans. The drugs, called cephalosporins, were given Source: www.newsday.com Farms: Salmonella Hurts Tomato Sales - Time With a salmonella scare causing many customers to shun what's normally a summertime favorite, tomato farmers nationwide have had to plow under their fields and leave their crop to rot in packinghouses. As losses across the supply chain top $100 Source: www.time.com FDA must require tracking of produce: food groups - Reuters WASHINGTON (Reuters) - As more Americans get sick while health officials look for the cause of a salmonella outbreak sweeping the country, consumer groups said on Thursday the Food and Drug Administration must put emergency rules in place to track Source: www.reuters.com How to stop superbugs - Boston Globe FOR ALL the breakthroughs medicine has achieved in treating cancer and heart disease, none has saved as many lives as the last century's discovery of antibiotics to treat infectious diseases. That is why physicians are so concerned about the Source: www.boston.com FDA panel urges more testing for diabetes drugs - Kansas City Star Diabetes drugs should face tougher safety standards that could cost manufacturers millions but protect patients from unforeseen heart risks, a government panel has recommended. Advisers to the Food and Drug Administration voted 14-2 on Wednesday that Source: www.kansascity.com FDA lifts clinical hold on Adolor bowel drug - CNN Money NEW YORK (Associated Press) - Adolor Corp. said Thursday the Food and Drug Administration has lifted its clinical hold on the company's Entereg drug in chronically constipated patients taking opioid pain drugs. The drug is being developed in Source: money.cnn.com Mylan gets FDA OK to market generic antibiotic - CNN Money NEW YORK (Associated Press) - Generic drug maker Mylan Inc. said Thursday it received tentative approval from the Food and Drug Administration to market its 600 milligram linezolid tablets. The antibiotic is a generic version of Pharmacia and Upjohn Source: money.cnn.com Diabetes meds need safety check, FDA is told - Fort Lauderdale Sun-Sentinel WASHINGTON - Diabetes drugs should face tougher safety standards that could cost manufacturers millions but protect patients from unforeseen heart risks, a government panel has recommended. Advisers to the Food and Drug Administration voted 14-2 on Source: www.sun-sentinel.com New Medical Products: New Non-Refrigerated Coagulation Product New Medical Products: New Non-Refrigerated Coagulation Product
FDA has approved a new formulation of the genetically engineered version of Factor VIIa that does not need to be refrigerated. Factor VIIa is a plasma protein essential for blood clotting that can be used to treat and prevent bleeding in people with... Rize 2 The Occasion Capsules and Rose 4 Her Capsules Certain lots of both products were recalled because they contained an undeclared ingredient. 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. 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. 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. July 4, 2008Leiner Health Products Issues Allergy Alert on Undeclared Allergens in Liquimax Multivitamin (June 6) 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. FDA lifts clinical hold on Adolor bowel drug - CNBC FDA lifts clinical hold on Adolor bowel drug - CNBC
EXTON, Pa. - Adolor Corp. said Thursday the Food and Drug Administration has lifted its clinical hold on the company's Entereg drug in chronically constipated patients taking opioid pain drugs. The drug is being developed in partnership with Source: www.cnbc.com Farmers say salmonella scare has hurt tomato sales - Forbes Expect fewer slices of red, ripe tomatoes next to the grill this holiday weekend. With a salmonella scare causing many customers to shun what's normally a summertime favorite, tomato farmers nationwide have had to plow under their fields and leave Source: www.forbes.com FDA panel urges more testing for diabetes drugs - Newsweek Recommended (6) How DC Is Nixing a Cancer Cure Is Diabetic Drug Effective? The War on HPV The War on HPV ON THE MARCH TO ERADICATE CHILD ILLNESS Turning the Tide? Nissen, the chairman of cardiology at the Cleveland Clinic, said the FDA is operating Source: www.newsweek.com FDA must require tracking of produce: food groups - Reuters WASHINGTON (Reuters) - As more Americans get sick while health officials look for the cause of a salmonella outbreak sweeping the country, consumer groups said on Thursday the Food and Drug Administration must put emergency rules in place to track Source: www.reuters.com FDA warns farms on antibiotic use - Newsday Inspectors found a common antibiotic has been misused in animals through practices such as injections into chicken eggs and ordered farmers to stop the unapproved treatments because of the risk to humans. The drugs, called cephalosporins, were given Source: www.newsday.com Preventing Medical Errors: Preventing Fatal Overdoses with Cerebyx Preventing Medical Errors: Preventing Fatal Overdoses with Cerebyx
The Institute for Safe Medication Practices (ISMP) and FDA are warning healthcare professionals that potentially fatal dosing errors continue to occur with the anti-epileptic drug Cerebyx (fosphenytoin), despite clarifications in the drug's labeling ... Myfortic (mycophenolate acid) Dear Healthcare Professional Letter sent by manufacturer regarding reports of Progressive Multifocal Leukoencephalopathy in patients treated with Myfortic. 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. February 2008 Monthly Safety Labeling Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. April 2008 Monthly Safety Labeling Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. 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. New Medical Products: New Skin Graft Adhesive Approved FDA recently approved a new medical adhesive called Artiss to attach skin grafts onto burn patients. Artiss is made by Baxter Healthcare. Artiss has a lower thrombin concentration than other fibrin sealants, which gives surgeons more time to posi... 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. Abbott says FDA OKs Xience V drug-coated stent for coronary artery - Forbes Abbott says FDA OKs Xience V drug-coated stent for coronary artery - Forbes
SAN FRANCISCO (Thomson Financial) - The Food and Drug Administration has approved Abbott Laboratories 's Xience V drug-coated stent for coronary disease, the Abbott Park, Ill.-based health-care company said late Wednesday. The stent will be launched Source: www.forbes.com FDA must require tracking of produce: food groups - Reuters FDA must require tracking of produce: food groups - Reuters
WASHINGTON (Reuters) - As more Americans get sick while health officials look for the cause of a salmonella outbreak sweeping the country, consumer groups said on Thursday the Food and Drug Administration must put emergency rules in place to track Source: www.reuters.com Abbott says FDA OKs Xience V drug-coated stent for coronary artery - CNBC SAN FRANCISCO (Thomson Financial) - The Food and Drug Administration has approved Abbott Laboratories's Xience V drug-coated stent for coronary disease, the Abbott Park, Ill.-based health-care company said late Wednesday. The stent will be launched Source: www.cnbc.com Boston Scientific Announces FDA Approval for PROMUS(TM) Everolimus - Forbes NATICK, Mass., July 2 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today announced that the U.S. Food and Drug Administration (FDA) has approved the PROMUS(TM) Everolimus-Eluting Coronary Stent System for the treatment of Source: www.forbes.com Steroid search at fire station - Honolulu Advertiser Agents with U.S. Immigration and Customs Enforcement and the U.S. Food and Drug administration searched the firefighter's locker on June 25 and seized several vials of liquid, authorities said. Source: www.honoluluadvertiser.com Adolor Provides Update on Entereg(R) (alvimopan) OBD Program - Forbes Adolor Corporation (Nasdaq: ADLR) today issued an update on the Entereg(R) (alvimopan) Program for chronic opioid bowel dysfunction (OBD), under development in collaboration with GlaxoSmithKline (NYSE: GSK). The U. S. Food and Drug Administration Source: www.forbes.com And Bring the Sunscreen - New York Times Summer is the time to slather exposed skin with sunscreen — the thicker, the higher the S.P.F., the better. Yet consumers are confused about which sunscreens work and which could be harmful to humans and the environment. The Food and Drug Source: www.nytimes.com Mylan gets FDA OK to market generic antibiotic - CNN Money NEW YORK (Associated Press) - Generic drug maker Mylan Inc. said Thursday it received tentative approval from the Food and Drug Administration to market its 600 milligram linezolid tablets. The antibiotic is a generic version of Pharmacia and Upjohn Source: money.cnn.com Abbott Gains FDA Approval For Xience Drug-Coated Stent - CNN Money Abbott Gains FDA Approval For Xience Drug-Coated Stent - CNN Money
Abbott Laboratories (ABT) gained approval Wednesday to begin selling its Xience drug-coated stent in the U.S., where the heart device is seen as a potential leader in domestic market worth more than $1.8 billion . The approval from the U.S. Food and Source: money.cnn.com Diabetes-drug testing pushed - Philadelphia Daily News WASHINGTON - Diabetes drugs should face tougher safety standards that could cost manufacturers millions, but protect patients from unforeseen heart risks, a government panel recommended. The Food and Drug Administration advisory panel voted, 14-2 Source: www.philly.com No Salad Days at FDA - Daily Herald WASHINGTON -- The latest E. coli/spinach and salmonella/tomatoes scares have renewed public concern about the Food and Drug Administration's oversight of food safety. And a recent Government Accountability Office report doesn't do much to put tomato Source: www.heraldextra.com Abbott says FDA OKs Xience V drug-coated stent for coronary artery - Forbes SAN FRANCISCO (Thomson Financial) - The Food and Drug Administration has approved Abbott Laboratories 's Xience V drug-coated stent for coronary disease, the Abbott Park, Ill.-based health-care company said late Wednesday. The stent will be launched Source: www.forbes.com Feds accuse Ariz. couple in Indian drug case - BusinessWeek A federal grand jury has indicted a Lake Havasu City, Ariz. couple who ran a company that allegedly imported Indian-made knockoffs of popular prescription drugs and sold them as U.S. versions. Randy T. French and his wife Sheila French face charges Source: www.businessweek.com Abbott rises after FDA approves Xience V stent - Forbes Shares of Abbott Laboratories rose Thursday after regulators approved its drug-coated Xience V stent for sale. The Food and Drug Administration approved the stent late Wednesday, and Abbott expects it to take between 25 percent and 30 percent of the Source: www.forbes.com Farmers say salmonella scare has hurt tomato sales - San Diego Union-Tribune With a salmonella scare causing many customers to shun what's normally a summertime favorite, tomato farmers nationwide have had to plow under their fields and leave their crop to rot in packinghouses. As losses across the supply chain top $100 Source: www.signonsandiego.com FDA Approves Abbott's XIENCE(TM) V Drug Eluting Stent - MSN MoneyCentral XIENCE V, Only Drug Eluting Stent to Demonstrate Superiority Over Market-Leading Stent in Clinical Trials, Now Available in United States for Treatment of Coronary Artery Disease ABBOTT PARK, Ill., July 2 /PRNewswire-FirstCall/ -- Abbott today Source: news.moneycentral.msn.com FDA: More diabetes drug testing needed - AZCentral.com WASHINGTON - Diabetes drugs would be subject to more stringent safety standards that could cost manufacturers millions, under recommendations made Wednesday by a government panel. Advisers to the Food and Drug Administration said overwhelmingly that Source: www.azcentral.com Abbott gets FDA approval for drug-coated stent - CNN Money NEW YORK (Associated Press) - Drug developer and medical device maker Abbott Laboratories said Wednesday it received Food and Drug Administration approval for its anticipated drug-coated stent, Xience V. The approval adds another drug-coated stent to Source: money.cnn.com Consumer groups want more from FDA - 10 News Consumer groups want more from FDA - 10 News
WASHINGTON — As you enjoy your holiday hamburger, with or without the tomato, consumer groups say the still unsolved salmonella outbreak is further proof the Food and Drug Administration needs to be more pro-active. Chris Waldrop of the Consumer Source: www.tampabays10.com FDA panel urges more testing for diabetes drugs - Salon Jul 2nd, 2008 | WASHINGTON -- Diabetes drugs would be subject to more stringent safety standards that could cost manufacturers millions, under recommendations made Wednesday by a government panel. Advisers to the Food and Drug Administration voted 14 Source: www.salon.com FDA Panel Calls for More Testing of Diabetes Drugs - Forbes WEDNESDAY, July 2 (HealthDay News) -- Drugs designed to control type 2 diabetes should be subjected to more thorough safety reviews to ensure they don't raise the risk of heart problems, U.S. Food and Drug Administration advisers said Wednesday. The Source: www.forbes.com FDA approves Abbott's next generation stent - News Sun ABBOTT PARK -- The U.S. Food and Drug Administration has approved Abbott Laboratories' next-generation Xience coronary stent system. At the same time, the company said that in two randomized head-to-head clinical trials, the Xience V is the only drug Source: www.suburbanchicagonews.com FDA Approves XIENCE V Drug Eluting Stent - eMaxHealth.com Abbott announced that FDA approved the XIENCE V Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease. XIENCE V is the only drug eluting stent to have demonstrated superiority over Boston Scientific's TAXUS paclitaxel Source: www.emaxhealth.com Diabetes meds need safety check, FDA is told - Hartford Courant WASHINGTON - Diabetes drugs should face tougher safety standards that could cost manufacturers millions but protect patients from unforeseen heart risks, a government panel has recommended. Advisers to the Food and Drug Administration voted 14-2 on Source: www.courant.com Farmers say salmonella scare has hurt tomato sales - Newsday FRESNO, Calif. - Expect fewer slices of red, ripe tomatoes next to the grill this holiday weekend. With a salmonella scare causing many customers to shun what's normally a summertime favorite, tomato farmers nationwide have had to plow under their Source: www.newsday.com Farmers say salmonella scare has hurt tomato sales - Newsday Farmers say salmonella scare has hurt tomato sales - Newsday
FRESNO, Calif. - Expect fewer slices of red, ripe tomatoes next to the grill this holiday weekend. With a salmonella scare causing many customers to shun what's normally a summertime favorite, tomato farmers nationwide have had to plow under their Source: www.newsday.com FDA Approves Abbott's XIENCE(TM) V Drug Eluting Stent - Yahoo Finance ABBOTT PARK, Illinois, July 2 /PRNewswire/ -- Abbott today announced that the U.S. Food and Drug Administration (FDA) approved the XIENCE(TM) V Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease. XIENCE V is the Source: biz.yahoo.com FDA Panel Calls for More Testing of Diabetes Drugs - Atlanta Journal Constitution WEDNESDAY, July 2 (HealthDay News) -- Drugs designed to control type 2 diabetes should be subjected to more thorough safety reviews to ensure they don't raise the risk of heart problems, U.S. Food and Drug Administration advisers said Wednesday. The Source: www.ajc.com Chinese Trader Convicted In Fake Drug Scheme - Click2Houston.com HOUSTON -- A federal jury convicted a Chinese trader on Thursday of a trying to send fake versions of prescription drugs to the United States. Kevin Xu, 36, is set to be sentenced in September after being found guilty of conspiracy, misbranding drugs Source: www.click2houston.com Feds accuse Ariz. couple in Indian drug case - BusinessWeek A federal grand jury has indicted a Lake Havasu City, Ariz. couple who ran a company that allegedly imported Indian-made knockoffs of popular prescription drugs and sold them as U.S. versions. Randy T. French and his wife Sheila French face charges Source: www.businessweek.com Boston Scientific Announces FDA Approval for PROMUS(TM) Everolimus - Forbes NATICK, Mass., July 2 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today announced that the U.S. Food and Drug Administration (FDA) has approved the PROMUS(TM) Everolimus-Eluting Coronary Stent System for the treatment of Source: www.forbes.com FDA 101: Advisory Committees FDA 101: Advisory Committees
FDA's Advisory Committees are critical to the agency's product review process. Find out the basics of putting special government employees with different perspectives on such scientific committees. Sage Products Inc. Issues Voluntary Recall of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation (June 27) As a precautionary measure, Sage Products announced a voluntary recall of limited lots of 2 Percent Chlorhexidine Gluconate (CHG) Cloth Patient Preoperative Skin Preparation product. Testing of bulk 2 Percent CHG solution from an outside supplier was found positive for Burkholderia cepacia (B. cepacia). Updated Press Release: Lake Country and LAND O LAKES Lamb Feed Voluntary Recall The Land O'Lakes Purina Feed plant in Fremont, Neb., has initiated a limited voluntary recall of four lamb feed products, packaged in 50-pound bags, due to the potential for higher than acceptable levels of copper. Bay Valley Foods Issues Allergy Alert on Undeclared Milk in Mislabeled Kroger Chicken Noodle Soup (June 24) The recalled product, Kroger Chicken Noodle Soup, comes in 10.5 ounce cans and is marked with lot code 52104098, and a "best before" date code of 40910 (April 9, 2010) that can be found on the bottom of the can. Consumers are urged to return the product to the store where it was purchased for a full refund. 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. FDA Panel Calls for More Testing of Diabetes Drugs - Atlanta Journal Constitution FDA Panel Calls for More Testing of Diabetes Drugs - Atlanta Journal Constitution
WEDNESDAY, July 2 (HealthDay News) -- Drugs designed to control type 2 diabetes should be subjected to more thorough safety reviews to ensure they don't raise the risk of heart problems, U.S. Food and Drug Administration advisers said Wednesday. The Source: www.ajc.com Diabetes meds need safety check, FDA is told - Hartford Courant WASHINGTON - Diabetes drugs should face tougher safety standards that could cost manufacturers millions but protect patients from unforeseen heart risks, a government panel has recommended. Advisers to the Food and Drug Administration voted 14-2 on Source: www.courant.com FDA panel urges more testing for diabetes drugs - San Francisco Gate Diabetes drugs would be subject to more stringent safety standards that could cost manufacturers millions, under recommendations made Wednesday by a government panel. Advisers to the Food and Drug Administration voted 14-2 that all new diabetes drugs Source: www.sfgate.com Farmers Say Salmonella Scare Has Hurt Tomato Sales - CBS News (AP) Expect fewer slices of red, ripe tomatoes next to the grill this holiday weekend. With a salmonella scare causing many customers to shun what's normally a summertime favorite, tomato farmers nationwide have had to plow under their fields and Source: www.cbsnews.com Boston Scientific Announces FDA Approval for PROMUS(TM) Everolimus - Forbes Boston Scientific Announces FDA Approval for PROMUS(TM) Everolimus - Forbes
NATICK, Mass., July 2 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today announced that the U.S. Food and Drug Administration (FDA) has approved the PROMUS(TM) Everolimus-Eluting Coronary Stent System for the treatment of Source: www.forbes.com Abbott gets FDA approval for drug-coated stent - CNN Money NEW YORK (Associated Press) - Drug developer and medical device maker Abbott Laboratories said Wednesday it received Food and Drug Administration approval for its anticipated drug-coated stent, Xience V. The approval adds another drug-coated stent to Source: money.cnn.com FDA Panel Calls for More Testing of Diabetes Drugs - Atlanta Journal Constitution WEDNESDAY, July 2 (HealthDay News) -- Drugs designed to control type 2 diabetes should be subjected to more thorough safety reviews to ensure they don't raise the risk of heart problems, U.S. Food and Drug Administration advisers said Wednesday. The Source: www.ajc.com CORRECTED: U.S. salmonella probe expands to Mexico: CNN - Reuters Fixes spelling of Columbia in second paragraph. WASHINGTON (Reuters) - The investigation of a salmonella outbreak in the United States is shifting to the southern border to encompass produce imported from Mexico, CNN reported on Thursday. U.S. health Source: www.reuters.com FDA Approves Abbott's XIENCE(TM) V Drug Eluting Stent - Yahoo Finance ABBOTT PARK, Illinois, July 2 /PRNewswire/ -- Abbott today announced that the U.S. Food and Drug Administration (FDA) approved the XIENCE(TM) V Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease. XIENCE V is the Source: biz.yahoo.com Collagen Wrinkle Filler Approved - Atlanta Journal Constitution THURSDAY, July 3 (HealthDay News) -- The U.S. Food and Drug Administration has approved Evolence to treat moderate-to-severe facial wrinkles and folds, maker Johnson & Johnson said Wednesday. The injected treatment is made from "naturally sourced Source: www.ajc.com Consumer groups seek tougher produce monitoring - Boston Globe WASHINGTON - Fruit and vegetable producers should be required to use technology that would allow regulators to trace the origin of contaminated produce, consumer groups said yesterday. Failure to identify the source of a salmonella outbreak that has Source: www.boston.com July 3, 2008Fry's parent expands ground-beef recall to Ariz. - AZCentral.com Fry's parent expands ground-beef recall to Ariz. - AZCentral.com
Arizonans preparing to fire up the grill for a Fourth of July cookout need to take an extra look at the labels on their ground beef. The Kroger Co., which owns Fry's Food Stores, announced Tuesday that it has expanded its recall of beef possibly Source: www.azcentral.com Consumer groups seek tougher produce monitoring - Boston Globe WASHINGTON - Fruit and vegetable producers should be required to use technology that would allow regulators to trace the origin of contaminated produce, consumer groups said yesterday. Failure to identify the source of a salmonella outbreak that has Source: www.boston.com FDA Panel Calls for More Testing of Diabetes Drugs - BusinessWeek WEDNESDAY, July 2 (HealthDay News) -- Drugs designed to control type 2 diabetes should be subjected to more thorough safety reviews to ensure they don't raise the risk of heart problems, U.S. Food and Drug Administration advisers said Wednesday. The Source: www.businessweek.com FDA Warns Individuals and Firms to Stop Selling Fake Cancer 'Cures' FDA Warns Individuals and Firms to Stop Selling Fake Cancer 'Cures'
Warning Letters have been sent to 23 U.S. companies and two foreign individuals marketing a wide range of products fraudulently claiming to prevent and cure cancer, according to the U.S. Food and Drug Administration today. 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. Abbott rises after FDA approves Xience V stent - MSN MoneyCentral Abbott rises after FDA approves Xience V stent - MSN MoneyCentral
NEW YORK (AP) - Shares of Abbott Laboratories rose Thursday after regulators approved its drug-coated Xience V stent for sale. The Food and Drug Administration approved the stent late Wednesday, and Abbott expects it to take between 25 percent and 30 Source: news.moneycentral.msn.com FDA Advisory Committee Recommends Cardiovascular Safety Studies for - Medscape News July 3, 2008 — New diabetes drugs should be subjected to studies to rule out cardiovascular risk, the FDA 's Endocrinologic and Metabolic Drugs Advisory Committee decided at a meeting this week. But the specifics of what exactly those studies Source: www.medscape.com FDA approves Boston Scientific stent - Minneapolis-St Paul Business Journal More funding, new leadership bolster Sinexus [San Jose] Boston Sci sells investments for $140M [Mpls./St. Paul] Weaving a tale of two med techs in Rhode Island [Mass High Tech] Boston Scientific Corp. announced Wednesday that the U.S. Food and Drug Source: twincities.bizjournals.com Sector Snap: Diabetes drug developers - MSN MoneyCentral Sector Snap: Diabetes drug developers - MSN MoneyCentral
Amylin Ord Shs ( AMLN ) Stock Quote , Chart , News , Add to Watchlist NEW YORK (AP) - Proposals for tougher heart-risk studies on new Type 2 diabetes drugs weighed heavy on shares of Amylin Pharmaceuticals Inc. and Novo Nordisk AS Thursday, since Source: news.moneycentral.msn.com Wyeth, Progenics bowel drug wins EU approval - Guardian Unlimited NEW YORK, July 3 (Reuters) - Wyeth and Progenics Pharmaceuticals Inc won European approval for Relistor, a drug used to treat constipation that occurs with the use of opioid painkillers, like morphine, the companies said on Thursday. The drug will be Source: www.guardian.co.uk Wyeth, Progenics get European constipation drug OK - Forbes Drug developers Wyeth and Progenics Pharmaceuticals Inc. said Thursday European regulators approved Relistor as a treatment for constipation related to pain drugs taken by terminally ill patients. The injectable drug relieves opioid-induced Source: www.forbes.com Radiology-centers chain is in default, FDA says - Baltimore Sun Radiology-centers chain is in default, FDA says - Baltimore Sun
A regional chain of radiology centers and its owner are in default on $1.1 million in fines for performing mammograms after one of its facilities lost its certification to perform the procedure because of equipment problems, according to documents Source: www.baltimoresun.com UPDATE 1-Adolor: FDA lifts hold on bowel drug; GSK may exit deal - Reuters July 3 (Reuters) - Adolor Corp (ADLR.O: Quote , Profile , Research , Stock Buzz ) said U. S. health regulators lifted a clinical hold on its drug Entereg, which is being developed to treat bowel dysfunction in patients on opioid therapy, but said Source: www.reuters.com FDA lifts clinical hold on Adolor bowel drug - CNN Money NEW YORK (Associated Press) - Adolor Corp. said Thursday the Food and Drug Administration has lifted its clinical hold on the company's Entereg drug in chronically constipated patients taking opioid pain drugs. The drug is being developed in Source: money.cnn.com Abbott rises after FDA approves Xience V stent - MSN MoneyCentral NEW YORK (AP) - Shares of Abbott Laboratories rose Thursday after regulators approved its drug-coated Xience V stent for sale. The Food and Drug Administration approved the stent late Wednesday, and Abbott expects it to take between 25 percent and 30 Source: news.moneycentral.msn.com Adolor gets FDA nod to resume Entereg testing - Philadelphia Inquirer The Food and Drug Administration said Adolor Corp. could resume clinical testing of its drug Entereg to treat bowel discomfort commonly associated with use of opioid painkillers, the Exton company said today. Development had been halted in April 2007 Source: www.philly.com Recalls and Safety Alerts: FDA Studying Heart Attack Risk with Ziagen, Videx Recalls and Safety Alerts: FDA Studying Heart Attack Risk with Ziagen, Videx
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 the information ... Myfortic (mycophenolate acid) Dear Healthcare Professional Letter sent by manufacturer regarding reports of Progressive Multifocal Leukoencephalopathy in patients treated with Myfortic. United States and China Outline Progress on Agreement on Food and Feed Safety (HHS Release) U.S. Secretary of Health and Human Services (HHS) Mike Leavitt signed a Joint Progress Statement today with the Honorable Li Changjiang, Minister of the General Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ) of the People�s Republic of China. The document outlines steps taken by both nations in implementing the 2007 Memorandum of Agreement (MOA) on food and feed safety. New Medical Products: New Skin Graft Adhesive Approved FDA recently approved a new medical adhesive called Artiss to attach skin grafts onto burn patients. Artiss is made by Baxter Healthcare. Artiss has a lower thrombin concentration than other fibrin sealants, which gives surgeons more time to posi... Recalls and Safety Alerts: FDA Takes Action on Injectable Colchicine FDA is taking action against companies marketing injectable colchicine, which is an unapproved form of the drug. Colchicine is an anti-inflammatory used in the treatment of gout. Colchicine tablets, which are less hazardous, are not affected by FDA... Adolor Provides Update on Entereg(R) (alvimopan) OBD Program - Forbes Adolor Provides Update on Entereg(R) (alvimopan) OBD Program - Forbes
Adolor Corporation (Nasdaq: ADLR) today issued an update on the Entereg(R) (alvimopan) Program for chronic opioid bowel dysfunction (OBD), under development in collaboration with GlaxoSmithKline (NYSE: GSK). The U. S. Food and Drug Administration Source: www.forbes.com Shire to add New Orphan Drug to its HGT Portfolio - EU Launch Imminent - MSN MoneyCentral Shire to add New Orphan Drug to its HGT Portfolio - EU Launch Imminent - MSN MoneyCentral
- FIRAZYR peak annual global sales expected to be around $350-400 million, based on current expectation of the competitive environment Shire Limited (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced today that Maia Source: news.moneycentral.msn.com Fighting Tooth and Nail - Baltimore Sun I t's a relatively small change - a rewritten page buried deep in the Food and Drug Administration Web site that will list possible health hazards from the use of mercury in dental fillings. But for a small, vocal group of advocates, it's the Source: www.baltimoresun.com FDA Approves Abbott's Xience V Drug Eluting Stent - Phramalive.com XIENCE V, Only Drug Eluting Stent to Demonstrate Superiority Over Market-Leading Stent in Clinical Trials, Now Available in United States for Treatment of Coronary Artery Disease ABBOTT PARK, Ill., July 02, 2008 /PRNewswire-FirstCall/ -- Abbott today Source: www.pharmalive.com Adolor Provides Update on Entereg(R) (alvimopan) OBD Program - MSN MoneyCentral The U. S. Food and Drug Administration (FDA) has concluded that clinical investigations relating to alvimopan in OBD may now proceed, and has therefore lifted the clinical hold on the OBD Investigational New Drug Application. “ After a productive Source: news.moneycentral.msn.com 2nd UPDATE: Skyepharma Up On Third Positive Flutiform Study - CNN Money LONDON -(Dow Jones)- Shares in U.K. pharmaceuticals company Skyepharma PLC ( SKP.LN) rose more than 10% Thursday after it successfully completed its third phase III study of asthma drug, Flutiform. Just one trial now remains before the company can Source: money.cnn.com FDA warns farms on antibiotic use - Newsday Inspectors found a common antibiotic has been misused in animals through practices such as injections into chicken eggs and ordered farmers to stop the unapproved treatments because of the risk to humans. The drugs, called cephalosporins, were given Source: www.newsday.com FDA backs Abbott stent - Chicago Tribune While U.S. approval of Abbott Laboratories ' drug-coated heart stent is a boost to the North Chicago medical giant, the product enters a market that is shrinking as doctors rethink the role of artery-clearing devices in the prevention of heart Source: www.chicagotribune.com Phytopharm sees FDA submission for weight product Hoodia in late 2009 - CNBC LONDON (Thomson Financial) - Phytopharm Plc. said it expects Hoodia extract, its weight management product partnered with Anglo-Dutch giant Unilever, to progress towards submission to the U.S. Food and Drug Administration by late in 2009. In an Source: www.cnbc.com February 2008 Monthly Safety Labeling February 2008 Monthly Safety Labeling
Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. FDA looks beyond tomatoes for salmonella source - Detroit News FDA looks beyond tomatoes for salmonella source - Detroit News
WASHINGTON -- Adding to tomato confusion, the government is about to start testing many other types of fresh produce in the hunt for the source of the nation's record salmonella outbreak -- even as it insists tomatoes are the leading suspect Source: www.detnews.com FDA panel urges more testing for diabetes drugs - NWITimes.com WASHINGTON - Diabetes drugs should face tougher safety standards that could cost manufacturers millions but protect patients from unforeseen heart risks, a government panel has recommended. Advisers to the Food and Drug Administration voted 14-2 on Source: nwitimes.com Shire to add New Orphan Drug to its HGT Portfolio - EU Launch Imminent - Forbes - Shire proposes acquisition of biotechnology company, Jerini AG for an equity purchase price of EUR328 million adding hereditary angioedema (HAE) product, FIRAZYR(R), to its Human Genetic Therapies (HGT) portfolio - FIRAZYR peak annual global sales Source: www.forbes.com Radiology-centers chain is in default, FDA says - Baltimore Sun A regional chain of radiology centers and its owner are in default on $1.1 million in fines for performing mammograms after one of its facilities lost its certification to perform the procedure because of equipment problems, according to documents Source: www.baltimoresun.com FDA Announces New Labeling Changes for Regranex 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. July 2, 2008FDA 101: How to Use the Consumer Complaint System and MedWatch 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. 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 Beware of Bug Bites and Stings Ticks, mosquitoes, and bees--here are tips for preventing and treating bug bites and stings. FDA Approves First Generic Risperidone to Treat Psychiatric Conditions The U.S. Food and Drug Administration today approved the first generic versions of Risperdal (risperidone) tablets. Risperdal is an antipsychotic drug used for the treatment of schizophrenia, bipolar disorder, and other psychiatric conditions. Giant Food Alerts Customers to Voluntary Recall of Giant Brand Garlic Bread and Garlic Spread (June 27) Giant Food Alerts Customers to Voluntary Recall of Giant Brand Garlic Bread and Garlic Spread (June 27)
Giant Food has announced a voluntary recall of Giant brand garlic bread and garlic spread products sold in its Bakeshop as the items contain milk products which are not declared on the labels. Giant removed from its shelves all 16 ounce packages of Giant brand garlic bread and all 16 ounce packages of Giant brand garlic spread products. Myfortic (mycophenolate acid) Dear Healthcare Professional Letter sent by manufacturer regarding reports of Progressive Multifocal Leukoencephalopathy in patients treated with Myfortic. 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. 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. Rize 2 The Occasion Capsules and Rose 4 Her Capsules Certain lots of both products were recalled because they contained an undeclared ingredient. February 2008 Monthly Safety Labeling Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. 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) 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. 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'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 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. Antipsychotics, Conventional and Atypical New studies show an increased risk of mortality in elderly patients treated for dementia-related psychosis with conventional antipsychotic drugs. Drug to be Discontinued: Kemadrin (procyclidine hydrochloride) Kemadrin (procyclidine hydrochloride), Dear Healthcare Professional Letter available for more information. 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. 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. Myfortic (mycophenolate acid) Dear Healthcare Professional Letter sent by manufacturer regarding reports of Progressive Multifocal Leukoencephalopathy in patients treated with Myfortic. 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. Trust for America's Health: New E. Coli Outbreak, Confusion Around - Forbes Trust for America's Health: New E. Coli Outbreak, Confusion Around - Forbes
TFAH Released Report in April, Recommending Systematic Changes WASHINGTON, July 2 /PRNewswire-USNewswire/ -- Richard Hamburg, Director of Government Relations for Trust for America's Health (TFAH), expressed concern about a new food safety breach Source: www.forbes.com FDA Approves Abbott's XIENCE(TM) V Drug Eluting Stent - Forbes ABBOTT PARK, Ill., July 2 /PRNewswire-FirstCall/ -- Abbott today announced that the U.S. Food and Drug Administration (FDA) approved the XIENCE(TM) V Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease. XIENCE V is Source: www.forbes.com FDA Warns Consumers in New Mexico and Texas Not to Eat Certain Types of Raw Red Tomatoes 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. 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. Fresca Italia, Inc., Expands Recall of Burrata Cheese Because of Possible Health Risk (June 23) Fresca Italia is recalling Burrata, a type of cheese, 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. 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. FDA 101: Biological Products FDA 101: Biological Products
Basic facts about biologics, products that replicate natural biologic substances such as enzymes, antibodies, or hormones in our bodies. FDA Food Protection Plan Shows Significant Progress The U.S. Food and Drug Administration's Food Protection Plan Progress Report, released today in conjunction with the Interagency Working Group on Import Safety Action Plan Update, shows significant areas of activity to further improve the safety of America�s food supply since unveiling its Food Protection Plan in November 2007. Beware of Bug Bites and Stings Ticks, mosquitoes, and bees--here are tips for preventing and treating bug bites and stings. 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. Red Tomato Warning Expanded Nationwide 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 tomatoes. 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. Yahoo jumps on report that Microsoft remains interested in buying - Minneapolis Star Tribune Yahoo jumps on report that Microsoft remains interested in buying - Minneapolis Star Tribune EU clears Nokia to buy mapmaker Navteq Drug, fraud trials set for Broadcom co-founder Citibank ATM breach reveals PIN security problems Bayreuth's Wagner festival will offer opera online Keeping a landline number on your cell phone NEW YORK - Shares Source: www.startribune.com Factory orders post weakest performance in 3 months as demand dips for - Minneapolis Star Tribune WASHINGTON - Orders to U.S. factories turned in the weakest performance in three months in May, reflecting slumping demand for autos, heavy machinery and steel. The Commerce Department reported Wednesday that factory orders rose by 0.6 percent in May Source: www.startribune.com Astra shares up 6 pct on Seroquel court ruling - Newsday LONDON - Shares in AstraZeneca PLC jumped 6 percent Wednesday after the drug maker won a key patent battle in the United States over Seroquel, its anti-psychotic drug and second-best seller. The decision by a U.S. court to award a summary judgment in Source: www.newsday.com Cardima, Inc. Receives Chinese State Food and Drug Administration - MSN MoneyCentral Cardima, Inc. (OTCBB: CADM) Cardima has been granted a market access license for the INTELLITEMP® by the SFDA and it is the first multichannel radiofrequency (RF) energy delivery device to receive approval for sale in China. The Company was Source: news.moneycentral.msn.com Research and Markets: An Analysis of the Challenges and Opportunities - Forbes Research and Markets (http://www.researchandmarkets.com/research/9aefbd/butter_margarine) has announced the addition of the "Butter, Margarine and Table Spreads in the United States 2008" report to their offering. The $5 billion market for butter Source: www.forbes.com FDA: Food protection plan shows progress - Political Gateway WASHINGTON, July 2 (UPI) -- The U.S. Food and Drug Administration says its plan to keep U.S. citizens enjoying one of the safest food supplies in the world shows significant progress. The FDA said its Food Protection Plan Progress Report, released Source: www.politicalgateway.com FDA clears Hansen Medical robotic product - MSN MoneyCentral Hansen Medical Inc., a developer of robotic technology for 3D control of catheter movement during cardiac procedures, said Wednesday it received U.S. Food and Drug A |
