October 18, 2008Dextroamphetamine Sulfate 5mg Tablets Dextroamphetamine Sulfate 5mg Tablets
Drug recall due to the potential for oversized tablets that may be associated with an increased risk of adverse effects. Nebion HLX-8 Magnetic Resonance Device Device recalled because it was not approved by FDA, lacked safety and effectiveness data, and was not manufactured under current good manufacturing practices. Epoetin alfa Preliminary safety findings from a German clinical trial showed more deaths in patients given epoetin-alpha versus placebo. Health Information Advisory on Infant Formula In response to reports of contaminated milk-based infant formula manufactured in China, FDA issued a Health Information Advisory on September 12, 2008. Drug Shortage: Fentanyl transdermal patch Availability information updated. Safety and Food Packaging FDA monitors all packaging that comes into contact with food. Here's an overview of how FDA conducts safety reviews of food contact substances. Draft Guidance on Genetically Engineered Animals The technology of genetic engineering offers many benefits for health, agriculture, and the environment. FDA tells how it is regulating genetically engineered animals. Improper Use of Decorative Contacts May Haunt You Halloween is a good time to remind people that improper use of non-prescription decorative contact lenses may harm your vision Potential Problems at Two Baltimore Pharmacies FDA is warning consumers who filled prescriptions at The Medicine Shoppe pharmacies located at 8035A Liberty Road and 5900 Reisterstown Road in Baltimore that they may have received drugs that were either expired or suspected counterfeit. Bottled Water Everywhere: Keeping it Safe Americans drink billions of gallons of bottled water each year. Find out about FDA's role in ensuring that bottled water products are safe. NY Fish Inc. Recalls Imperial-European Style Smoked Salmon Because of Possible Health Risk (September 26) NY Fish Inc. Recalls Imperial-European Style Smoked Salmon Because of Possible Health Risk (September 26)
NY FISH INC. of Brooklyn, NY, is recalling I [heart symbol] NY FISH brand IMPERIAL-EUROPEAN STYLE SMOKED SALMON, vacuum packed, in 3 oz., 8 oz., 16 oz., and whole sides (“to be weighed at time of sale”) sizes with lot numbers 513 1340, 514 1340, 515 1340, and 516 1340, because they have the potential to be contaminated with Listeria monocytogenes. FDA Detects Melamine Contamination in Flavored Drink The U.S. Food and Drug Administration (FDA) has increased inspections and product testing efforts in response to the melamine contamination problem which originated in Chinese dairy products. As a result of the FDA's on-going testing program, the agency has detected melamine contamination in Blue Cat Flavor Drinks. The distributor of the product, Tristar Food Wholesale Co. Inc., initiated a recall of several flavors of Blue Cat Flavor Drink, based on the FDA’s findings. The FDA advises the public not to consume this product and recommends that retailers and food service operators remove the product from sale or service. Over The Counter Cough and Cold Medications Over The Counter Cough and Cold Medications
Product labels being modified to state "do not use" in children under 4 years of age. Mr. Brown 3-In-1 and and 2-In-1 Powdered Packets in Bag Coffee Mixes Due To Health Risk (October 1) The recall was initiated after the manufacturer notified Sunny Maid that these 3-in-1 and 2-in-1 Coffee Mix products may contain melamine. Although only certain lots are potentially contaminated, Sunny Maid is recalling all lots. No illnesses associated with this product have been reported to date. QFCO, Inc. Recalls White Rabbit Candy Because of Possible Health Risk (September 26) QFCO, Inc. of Burlingame, California is recalling White Rabbit Candy because it may be contaminated with Melamine. Product was distributed to the states of CA, GA, HI, IL, MN, NY, OR, TX, WA through wholesale distributors to retail stores. Nebion HLX-8 Magnetic Resonance Device Device recalled because it was not approved by FDA, lacked safety and effectiveness data, and was not manufactured under current good manufacturing practices. Ammonul (sodium phenylacetate and sodium benzoate) Injection 10%/10% Particulate matter detected in product. Healthcare providers instructed to use a filter during the admixture process. Fineland Corp Issues Alert on Undeclared Sulfites in Ying Feng Foodstuffs Brand Pumpkin Seeds (September 23) Ying Feng Foodstuffs Brand Pumpkin Seeds is sold in a 10 ounce, clear plastic package with the following code: EXP 03 25 2010 and was distributed nationwide. It is a product of China. Consumer Alert: Possible Botulism Contamination in Frozen Salted Croaker (October 6) New York State Agriculture Commissioner alerted consumers not to eat Frozen Salted Croaker distributed by YS Trading Corp, Long Island City, New York because the product was uneviscerated. The Frozen Salted Croaker was sold in Hicksville, New York, Flushing, New York, and New Jersey in un-coded, unlabeled plastic bags. Statin drugs and amyotrophic lateral sclerosis (ALS) New analysis of 41 long-term controlled clinical trials provides evidence that use of statins does not increase incidence of ALS. Potential Problems at Two Baltimore Pharmacies FDA is warning consumers who filled prescriptions at The Medicine Shoppe pharmacies located at 8035A Liberty Road and 5900 Reisterstown Road in Baltimore that they may have received drugs that were either expired or suspected counterfeit. Mars Petcare US Issues Voluntary Recall of Everson, PA Plant Dry Pet Food Product due to Potential Salmonella Contamination (September 12) Mars Petcare US announced a voluntary recall of products manufactured at its Everson, Pennsylvania facility. The pet food is being voluntarily recalled because of potential contamination with Salmonella serotypeSchwarzengrund. This voluntary recall only affects the United States. Drug Shortages: Drugs to be Discontinued; Cefotan (cefotetan injection)- updated Drug Shortages: Drugs to be Discontinued; Cefotan (cefotetan injection)- updated
See additional information in Related Information section. Drug Shortages: Resolved Drug Shortages; Zanosar (Streptozocin) 1gm/vial Injection See Web site for additional information K-Fat Inc. Issues Alert On Undeclared Sulfites In "Mut Gung Sweetened Ginger" (September 18) K-FAT INC. of 13 Meadow St., Brooklyn, NY 11206, is recalling its 150g packages of MUT GUNG SWEETENED GINGER because they contain undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious life-threatening allergic reactions if they consume this product. Mars Petcare US Issues Voluntary Recall of Everson, PA Plant Dry Pet Food Product due to Potential Salmonella Contamination (September 12) Mars Petcare US announced a voluntary recall of products manufactured at its Everson, Pennsylvania facility. The pet food is being voluntarily recalled because of potential contamination with Salmonella serotypeSchwarzengrund. This voluntary recall only affects the United States. Allergy Alert on Undeclared Dairy in Margaritaville Island Lime Tortilla Chips (September 12) El Matador Enterprises, makers of Margaritaville Tortilla Chips is voluntarily recalling 13-ounce bags of Margaritaville Island Lime Tortilla Chips because they may contain undeclared whey in the spice blend. Drug Shortages: Current Drug Shortages; Zanosar (Streptozocin) Injection See Web site for additional information on this current drug shortage Drug Shortages: Current Drug Shortages; Methadone Hydrochloride Injection See Web site for additional information on this current drug shortage NY Fish Inc. Recalls Imperial-European Style Smoked Salmon Because of Possible Health Risk (September 26) NY FISH INC. of Brooklyn, NY, is recalling I [heart symbol] NY FISH brand IMPERIAL-EUROPEAN STYLE SMOKED SALMON, vacuum packed, in 3 oz., 8 oz., 16 oz., and whole sides (“to be weighed at time of sale”) sizes with lot numbers 513 1340, 514 1340, 515 1340, and 516 1340, because they have the potential to be contaminated with Listeria monocytogenes. Drug Shortages: Current Drug Shortages; Phospholine Iodide, Ophthalmic solution See Web site for additional information on this current drug shortage Drug Shortage: Drug to be Discontinued; Revex (Nalmefene HCl Injection) Baxter has discontinued Revex production. Genentech's Raptiva receives new FDA warning - Seattle Times Genentech's Raptiva receives new FDA warning - Seattle Times
The Food and Drug Administration said Thursday it will update the labeling of Genentech Inc.'s psoriasis drug Raptiva to highlight the risk of several bacterial and viral conditions. The added warnings follow Genentech's announcement earlier this Source: seattletimes.nwsource.com How Obama Would Stifle Drug Innovation - Wall Street Journal Pfizer recently said it's exiting the development of drugs for common conditions like heart disease. This is part of a shift underway in the pharmaceutical industry to give up on routine medical problems in favor of discovering "specialty" drugs for Source: online.wsj.com Family Blames Soldier's Suicide on Anti-Malaria Drug - Washington Post Susana Ferro, shown with her son Juan "John" Torres before he deployed for Afghanistan, blames the anti-malaria drug Lariam for his 2004 suicide. (Courtesy of Susana Ferro) CHICAGO -- Juan Torres didn't believe that his son, Army Reservist Juan "John Source: www.washingtonpost.com Merck expands international cholesterol drug study to get faster - Minneapolis Star Tribune TRENTON, N.J. - Merck & Co. is expanding an already-large study of an experimental cholesterol drug — rejected this spring by U.S. regulators — to get results sooner so it can move up its second bid for approval. The drug, known as MK-0524A Source: www.startribune.com More Delays For Lilly's Heart Drug - Forbes Prasugrel, an experimental drug that is key to pharmaceutical company Eli Lilly 's future, may be delayed months longer than investors expected. The Food and Drug Administration has asked cardiologists to mark some time in their calendars for a Source: www.forbes.com Ailing Democratic donor obtains experimental drug - NWITimes.com DALLAS - An ailing Democratic fundraiser has obtained an experimental cancer-fighting drug through the Mayo Clinic, according to his son, despite the drug maker's refusal to sanction the treatment. Fred Baron, a prominent political donor linked to Source: nwitimes.com HHS Preparing to Open FDA Offices in China, India, Europe, and Latin - WebWire The U.S. Department of Health and Human Services will send the first U.S. Food and Drug Administration (FDA) staff to China, India, Europe, and Latin America before the end of 2008, HHS Secretary Mike Leavitt announced today. “We’re making steady Source: www.webwire.com October 17, 2008US clears Lev Pharma drug for rare swelling disease - Reuters US clears Lev Pharma drug for rare swelling disease - Reuters
WASHINGTON, Oct 10 (Reuters) - U.S. health regulators on Friday approved Lev Pharmaceuticals Inc's (LEVP.OB: Quote , Profile , Research , Stock Buzz ) experimental drug to treat a rare genetic disease that causes swelling of the hands, feet and other Source: www.reuters.com $894 million deal ends pain of Pfizer's lawsuits - International Herald Tribune TRENTON, N.J. : Drug giant Pfizer Inc. has reached an $894 million deal to settle the bulk of the lawsuits over its withdrawn pain reliever Bextra, following the lead of rival Merck & Co., which is spending five times as much to settle Vioxx suits Source: www.iht.com Family Blames Soldier's Suicide on Anti-Malaria Drug - Washington Post Susana Ferro, shown with her son Juan "John" Torres before he deployed for Afghanistan, blames the anti-malaria drug Lariam for his 2004 suicide. (Courtesy of Susana Ferro) CHICAGO -- Juan Torres didn't believe that his son, Army Reservist Juan "John Source: www.washingtonpost.com Family Blames Soldier's Suicide on Anti-Malaria Drug Lariam Known to - Washington Post CHICAGO -- Juan Torres didn't believe that his son, Army Reservist Juan "John" M. Torres, had killed himself in Afghanistan just weeks before he was to return home in July 2004. He figured that John, 25, was murdered because of his opposition to the Source: www.washingtonpost.com Canada to declare BPA a hazardous substance - International Herald Tribune TORONTO : Canada will be the first country to limit the importation and use of products containing an ubiquitous chemical found in hard plastic water bottles and baby bottles, metal cans and other food packaging when it formally declares bisphenol A Source: www.iht.com Genentech's Raptiva receives new FDA warning - San Francisco Gate The Food and Drug Administration said Thursday it will update the labeling of Genentech Inc.'s psoriasis drug Raptiva to highlight the risk of several bacterial and viral conditions. The added warnings follow Genentech's announcement earlier this Source: www.sfgate.com HHS Preparing to Open FDA Offices in China, India, Europe, and Latin - WebWire The U.S. Department of Health and Human Services will send the first U.S. Food and Drug Administration (FDA) staff to China, India, Europe, and Latin America before the end of 2008, HHS Secretary Mike Leavitt announced today. “We’re making steady Source: www.webwire.com Daiichi Sankyo, Eli Lilly: New drug still on track - Forbes Japanese drug maker Daiichi Sankyo Co. and U.S. partner Eli Lilly & Co. sought to reassure investors Friday that a highly anticipated blood thinner remains on track for approval, despite escalating concerns of further delays by federal health Source: www.forbes.com FDA will seek advice on new version of a Genzyme drug - Boston Globe The Food and Drug Administration will ask a panel of experts week whether studies by the Cambridge biotech firm Genzyme Corp. support approval of a new version of its drug Myozyme. Genzyme markets Myozyme for Pompe disease, a rare disorder that Source: www.boston.com Tiotropium (marketed as Spiriva HandiHaler) Tiotropium (marketed as Spiriva HandiHaler)
UPDATE - Preliminary results of the UPLIFT Trial shows no increased risk of stroke with tiotropium bromide. Two recent publications reported increased risk for mortality and/or cardiovascular events in patients who received tiotropium or inhaled anticholinergics. Consumer Alert: Undeclared Sulfites in Shad Raisins (October 6) New York State Agriculture Commissioner alerted consumers that Fatima Brothers Inc. of Maspeth, New York is recalling Shad Raisins due to the presence of undeclared sulfites. The recalled Shad Raisins were packaged in uncoded, 7-ounce plastic bags. Shad Raisins were distributed in New York City. K-Fat Inc. Issues Alert On Undeclared Sulfites In "Mut Gung Sweetened Ginger" (September 18) K-FAT INC. of 13 Meadow St., Brooklyn, NY 11206, is recalling its 150g packages of MUT GUNG SWEETENED GINGER because they contain undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious life-threatening allergic reactions if they consume this product. Nebion HLX-8 Magnetic Resonance Device Device recalled because it was not approved by FDA, lacked safety and effectiveness data, and was not manufactured under current good manufacturing practices. Raptiva (efalizumab) Risk of life-threatening infections associated with Raptiva use. Bimbo Bakeries USA Issues an Allergy Alert on Undeclared Tree Nuts in Oroweat 100 Percent Whole Wheat Bread Packaging (September 16) Bimbo Bakeries USA today announced a voluntary recall of Oroweat 100 Percent Whole Wheat bread because it may contain tree nuts that are not listed on the label. Individuals with allergies to tree nuts run the risk of a serious and or life threatening reaction if they consume this product. FDA Approves Use of Temporary Pump to Assist Heart's Right Side The U.S. Food and Drug Administration approved a Humanitarian Device Exemption (HDE) for the first heart pump that provides certain critically ill patients with temporary support for the right side of their heart. Heart assist devices are mechanical pumps that aid in the pumping action of a weakened heart. Most heart assist devices support the heart's left ventricle, which pumps oxygen-rich blood to the rest of the body. The CentriMag Right Ventricular Assist System is intended for patients requiring support for the heart's right ventricle, which passes oxygen-depleted blood to the lungs to be refreshed with oxygen. Derringer Foodservices Issues Allergy Alert on Albacore Tuna Salad Hoagie (September 17) This product is being recalled due to the omission of egg in the ingredient statement following the ingredient Reduced Calorie Mayonnaise. The recall decision was based on a potential allergen was included in the product and excluded from the label ingredient statement. This label omission was discovered in a standard ingredient statement audit. Epoetin alfa Preliminary safety findings from a German clinical trial showed more deaths in patients given epoetin-alpha versus placebo. Russell Stover Candies, Inc. Issues Hazelnut Allergy Alert for the 2 7/8 Oz Size Of Private Reserve Assorted Chocolates (October 9) The recalled product was distributed in the following states and cities: Texas, California, Louisiana, North Carolina, South Carolina, Virginia, Tennessee; Southaven, Mississippi; Billings, Montana; Sparks, Nevada; and Madison Heights, Michigan. An investigation determined 29 boxes of this candy may have been purchased by consumers, and up to another 188 boxes may have reached retail store locations. All the retail stores have been contacted to have the suspected product removed from the shelves. FDA and PATH Malaria Vaccine Initiative Announce Research Collaboration FDA and PATH Malaria Vaccine Initiative Announce Research Collaboration
The U.S. Food and Drug Administration has announced a collaboration with the PATH Malaria Vaccine Initiative (PATH-MVI) to develop laboratory tests to better predict the level of safety and effectiveness of experimental malaria vaccines before they are used in human clinical trials. Meda: the FDA Approves Astepro - Phramalive.com Meda: the FDA Approves Astepro - Phramalive.com
The U.S. Food and Drug Administration (FDA) has approved Astepro - the new formulation of Astelin. Astepro Nasal Spray is an improvement over the marketed Astelin Nasal Spray and is better tolerated by patients using the new spray. The active Source: www.pharmalive.com UPDATE 1-Pozen says FDA reviewing main goal of trials - Reuters Oct 17 (Reuters) - Pozen Inc (POZN.O: Quote , Profile , Research , Stock Buzz ) said U.S. health regulators are conducting an internal review on the acceptability of using endoscopic gastric ulcers as a main goal in clinical studies and it was unsure Source: www.reuters.com FDA will open office in China - Miami Herald The Food and Drug Administration will establish its first office in China before the end of the year as part of a broader plan to assure the safety of imports from the developing world. FDA Commissioner Andrew von Eschenbach laid out a plan to place Source: www.miamiherald.com Market Report -- In Play (WIRES) - MSN MoneyCentral On The Wires POZEN ( POZN ) announces co and GlaxoSmithKline ( GSK ), the holder of the NDA for Treximet, received a letter from Par Pharmaceutical ( PRX ) notifying POZEN and GSK that Par submitted an Abbreviated New Drug Application to the FDA for Source: news.moneycentral.msn.com FDA will open an outpost in China this year - Boston Globe WASHINGTON - The Food and Drug Administration will establish its first office in China before the end of the year as part of a broader plan to assure the safety of imports from the developing world. FDA Commissioner Andrew von Eschenbach laid out a Source: www.boston.com POZEN Informed of FDA Internal Review of Gastric Ulcers as a Primary - MSN MoneyCentral POZEN Inc. POZN , today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that, as part of the FDA ’ s on-going discussions with the Company and their review of both the Special Protocol Assessment (SPA) for Source: news.moneycentral.msn.com Genentech's Raptiva receives new FDA warning - Seattle Times Genentech's Raptiva receives new FDA warning - Seattle Times
The Food and Drug Administration said Thursday it will update the labeling of Genentech Inc.'s psoriasis drug Raptiva to highlight the risk of several bacterial and viral conditions. The added warnings follow Genentech's announcement earlier this Source: seattletimes.nwsource.com Daiichi Sankyo, Eli Lilly: New drug still on track - International Herald Tribune TOKYO : Japanese drug maker Daiichi Sankyo Co. and U.S. partner Eli Lilly & Co. sought to reassure investors Friday that a highly anticipated blood thinner remains on track for approval, despite escalating concerns of further delays by federal health Source: www.iht.com Produce Industry Looks To Improve Labeling - Tampa Bay Online WASHINGTON - Prompted by this summer's salmonella outbreak, the government has begun investigating how to quickly identify the source of contaminated food and stop it from getting to consumers. At the first public hearing on the issue Thursday Source: www2.tbo.com Drug, stent makers collaborate on anti-clot study - San Francisco Gate Several competing drug and medical device makers are starting an international collaboration to find out the best way to prevent potentially deadly blood clots from forming in heart patients who have artery-opening stents implanted. At issue in the Source: www.sfgate.com UPDATE 2-U.S. calls for new warnings on Genentech skin drug - Reuters WASHINGTON, Oct 16 (Reuters) - U.S. health regulators have ordered strong black-box warnings for Genentech Inc's (DNA.N: Quote , Profile , Research , Stock Buzz ) psoriasis drug, Raptiva, saying patients given the once-weekly injections are at risk Source: www.reuters.com HHS Preparing to Open FDA Offices in China, India, Europe, and Latin - PR Inside - HHS Press Office 202-690-6343 The U.S. Department of Health and Human Services will send the first U.S. Food and Drug Administration (FDA) staff to China, India, Europe, and Latin America before the end of 2008, HHS Secretary Mike Leavitt announced Source: www.pr-inside.com October 16, 2008FDA seeks advice to improve tracking of produce - San Diego Union-Tribune FDA seeks advice to improve tracking of produce - San Diego Union-Tribune
WASHINGTON – Prompted by this summer's salmonella outbreak, the government has begun investigating how to quickly identify the source of contaminated food and stop it from getting to consumers. At the first public hearing on the issue Thursday Source: www.signonsandiego.com US will open inspection office in China this year - International Herald Tribune WASHINGTON : Food and Drug Administration officials say the agency will establish its first office in China before the end of the year. It's part of a broader plan to assure the safety of imports from the developing world. FDA Commissioner Andrew von Source: www.iht.com FDA Sets China For First Overseas Office; More To Follow - Wall Street Journal WASHINGTON (AFP)--The U.S. Food and Drug Administration will open its first overseas offices in China this year, as part of efforts to regulate food sent to the United States, an official said Thursday. Offices will also be opened in India, Europe Source: online.wsj.com FDA Law Enforcers Crack Down on Illegal Botox Scammer FDA Law Enforcers Crack Down on Illegal Botox Scammer
FDA's Office of Criminal Investigations found physicians who put profit before patients when they injected them with fake Botox Cosmetic. Drug Shortages: Current Drug Shortages; Phospholine Iodide, Ophthalmic solution See Web site for additional information on this current drug shortage FDA and PATH Malaria Vaccine Initiative Announce Research Collaboration FDA and PATH Malaria Vaccine Initiative Announce Research Collaboration
The U.S. Food and Drug Administration has announced a collaboration with the PATH Malaria Vaccine Initiative (PATH-MVI) to develop laboratory tests to better predict the level of safety and effectiveness of experimental malaria vaccines before they are used in human clinical trials. CaJohns Fiery Foods Company Recalls HDH Grillin' Sauce (September 24) CaJohns Fiery Foods Company is recalling a total of 103 individual bottles of HDH Grillin' Sauce sold between the dates of 01/01/07 and 09/15/08. This recall is initiated due to the possibility of non-declared contents on the Ingredient Declaration. The products contain the listed Worcestershire Sauce, but may not be parenthetically listed as to it's ingredients one of which is Anchovies, a serious allergen to specific individuals. These products also contain the listed Soy Sauce, but may not be parenthetically listed as to it's ingredients. Soy Sauce contains Soybeans and Wheat which are serious allergens to specific individuals. FDA Licenses for Marketing New Therapy for Rare Genetic Disease The U.S. Food and Drug Administration today licensed for marketing the first product in the United States intended to protect people with hereditary angioedema (HAE), a rare and potentially life-threatening genetic disease. HAE affects about 6,000 to 10,000 individuals in the United States. Derringer Foodservices Issues Allergy Alert on Albacore Tuna Salad Hoagie (September 17) This product is being recalled due to the omission of egg in the ingredient statement following the ingredient Reduced Calorie Mayonnaise. The recall decision was based on a potential allergen was included in the product and excluded from the label ingredient statement. This label omission was discovered in a standard ingredient statement audit. Ralston Foods Issues Allergy Alert For Undeclared Milk Ingredients In Western Family Variety Pack Instant Oatmeal (September 15) Ralston Foods, Division of Ralcorp Holdings, Inc. is recalling 14664 cartons of Western Family Variety Pack Instant Oatmeal cereal bearing the "Best If Used By" Date Code of "DEC0409N" (found on the box top) because a small number of cartons contain an undeclared milk ingredient. FDA Issues Health Information Advisory on Infant Formula In response to reports of contaminated milk-based infant formula manufactured in China, the U.S. Food and Drug Administration (FDA) today is issuing a Health Information Advisory. This is to assure the American public that there is no known threat of contamination in infant formula manufactured by companies that have met the requirements to sell infant formula in the United States. Although no Chinese manufacturers of infant formula have fulfilled the requirements to sell infant formula in the United States, FDA officials are investigating whether or not infant formula manufactured in China is being sold in specialty markets which serve the Asian community. FDA Licenses Drug to Prevent Joint Damage in Children with Hemophilia A The U.S. Food and Drug Administration today approved a new use for the blood product Kogenate FS to reduce the frequency of bleeding episodes and prevent joint damage in children with the most severe form of hemophilia. October 15, 2008Newer vaccine may be better for polio hot spots - MSNBC Newer vaccine may be better for polio hot spots - MSNBC
BOSTON - A newer vaccine that targets the most common form of the polio virus works up to four times better than the conventional vaccine that tries to protect against all three types of the crippling disease, researchers said on Wednesday. The so Source: www.msnbc.msn.com Dying lawyer's son implores Biogen Idec - Boston Globe NEW YORK - The son of Fred Baron is pleading with Biogen Idec Inc. to let his dying father, the Dallas trial lawyer who served as finance chairman for John Edwards's presidential campaign, use the experimental cancer drug Tysabri. "All we need is for Source: www.boston.com FDA will look into scientist's possible conflict - AOL WASHINGTON -Federal health officials said Tuesday they will look into a possible conflict of interest involving a prominent toxicologist who is heading up a review of a sensitive safety issue. Several lawmakers said the controversy could undermine Source: news.aol.com Tort lawyer Fred Baron dying of cancer, denied experimental drug, son - Dallas Morning News The elder Mr. Baron, 61, was a founder in the Baron & Budd law firm, though he and his wife, Lisa Blue, sold their interest in the firm several years ago. He was most recently in the news because of his financial connection to former senator and Source: www.dallasnews.com Amylin continues slide on diabetes drug concerns - MSN MoneyCentral NEW YORK (AP) - Shares of Amylin Pharmaceuticals Inc. fell Thursday, as investors remained concerned about the company's third-quarter sales for the diabetes treatment Byetta and regulatory timeline for an extended-release version of the drug Source: news.moneycentral.msn.com K-Fat Inc. Issues Alert On Undeclared Sulfites In "Mut Gung Sweetened Ginger" (September 18) K-Fat Inc. Issues Alert On Undeclared Sulfites In "Mut Gung Sweetened Ginger" (September 18)
K-FAT INC. of 13 Meadow St., Brooklyn, NY 11206, is recalling its 150g packages of MUT GUNG SWEETENED GINGER because they contain undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious life-threatening allergic reactions if they consume this product. Consumer Alert: Possible Botulism Contamination in Frozen Salted Croaker (October 6) New York State Agriculture Commissioner alerted consumers not to eat Frozen Salted Croaker distributed by YS Trading Corp, Long Island City, New York because the product was uneviscerated. The Frozen Salted Croaker was sold in Hicksville, New York, Flushing, New York, and New Jersey in un-coded, unlabeled plastic bags. NY Fish Inc. Recalls Imperial-European Style Smoked Salmon Because of Possible Health Risk (September 26) NY FISH INC. of Brooklyn, NY, is recalling I [heart symbol] NY FISH brand IMPERIAL-EUROPEAN STYLE SMOKED SALMON, vacuum packed, in 3 oz., 8 oz., 16 oz., and whole sides (“to be weighed at time of sale”) sizes with lot numbers 513 1340, 514 1340, 515 1340, and 516 1340, because they have the potential to be contaminated with Listeria monocytogenes. FDA 101: Dietary Supplements Part of the "FDA 101" series, this article describes how dietary supplements are regulated and offers safety tips for consumers. Fineland Corp Issues Alert on Undeclared Sulfites in Ying Feng Foodstuffs Brand Pumpkin Seeds (September 23) Ying Feng Foodstuffs Brand Pumpkin Seeds is sold in a 10 ounce, clear plastic package with the following code: EXP 03 25 2010 and was distributed nationwide. It is a product of China. FDA Seeks Data on Medical Devices, Drugs Containing BPA - Wall Street Journal FDA Seeks Data on Medical Devices, Drugs Containing BPA - Wall Street Journal
WASHINGTON -- The Food and Drug Administration on Wednesday said it wants help identifying what medical devices, drugs and other products it regulates contain Bisphenol-A, a potentially harmful chemical commonly found in plastic containers such as Source: online.wsj.com FDA: Stop the birth control lies! - Salon FDA: Stop the birth control lies! - Salon
Get this: Apparently advertisers sometimes target women with intentionally misleading advertisements -- and, brace yourselves, pharmaceutical companies are among the major offenders. (And I thought Big Pharma was a good pal.) Bayer is the latest Source: www.salon.com Prozac on the Playground - Slate Problem : We are now more aware of emotional illness in children and much more likely to diagnose and treat conditions like attention deficit disorders. But as difficult and expensive as it is to test new medications on adults, it's even harder to do Source: www.slate.com FDA Seeks Data on Medical Devices, Drugs Containing BPA - Wall Street Journal WASHINGTON -- The Food and Drug Administration on Wednesday said it wants help identifying what medical devices, drugs and other products it regulates contain Bisphenol-A, a potentially harmful chemical commonly found in plastic containers such as Source: online.wsj.com Wyeth postpones seeking Pristiq approval in Europe - Forbes Drug developer Wyeth said Wednesday it will postpone pursuing regulatory approval for its antidepressant Pristiq in Europe and is conducting additional late-stage studies on the drug. The Committee for Medicinal Products for Human Use of the European Source: www.forbes.com Cleveland BioLabs Doses First Healthy Volunteer in Initial Safety - MSN MoneyCentral Cleveland BioLabs, Inc. (NASDAQ: CBLI) today announced that on October 14, the first healthy volunteer was dosed in the initial human safety study for Protectan CBLB502, a drug under development for the treatment for Acute Radiation Syndrome (ARS Source: news.moneycentral.msn.com Melamine found in Thai condensed milk - International Herald Tribune BANGKOK : Thailand's Food and Drug Administration (FDA) said Wednesday it had found "very high" levels of melamine in a sample of unsweetened condensed milk produced and sold in the country. The FDA ordered Thai Dairy Industry Co. Ltd. to stop Source: www.iht.com LabCorp ovarian cancer test sales illegal: FDA - Reuters WASHINGTON (Reuters) - Laboratory Corp of America is violating the law by selling an ovarian cancer screening test without regulatory approval, U.S. health officials said on Wednesday. The OvaSure test does not fall in a category that can be sold Source: www.reuters.com Detroit firm resumes lettuce packaging amid ongoing E. coli probe - Detroit Free Press Detroit firm resumes lettuce packaging amid ongoing E. coli probe - Detroit Free Press
The Michigan Department of Agriculture did product and environmental sample testing at Aunt Mid’s the last week of September and additional testing was conducted by the state health department, Michigan State University, the federal Food and Drug Source: www.freep.com Free Prescription Drug Samples Pose Risk to Kids - BusinessWeek Free Prescription Drug Samples Pose Risk to Kids - BusinessWeek
The study, published in the October 2008 issue of Pediatrics , examined data on 10,295 children and adolescents from the 2004 Medical Expenditure Panel Survey. The researchers found that one in 20 American children received free drug samples in 2004 Source: www.businessweek.com Charles River Expands Global Footprint with Shanghai Facility Opening - MSN MoneyCentral To support the growing demand from multinational pharmaceutical clients for outsourced drug development services, Charles River Laboratories International, Inc. CRL today announced the opening of its 60,000 square foot preclinical facility in Source: news.moneycentral.msn.com Tribendimidine shows promise against intestinal worms - Science Centric Researchers have reported positive results from a safety and efficacy study pertaining to tribendimidine, a broad-based treatment for intestinal worm infections. The group's results demonstrate the success of the new drug from China versus that of Source: www.sciencecentric.com Cypress Pharmaceutical, Inc. Receives FDA Approval of Cetirizine - Phramalive.com MADISON, Miss.--(BUSINESS WIRE)--Oct 15, 2008 - Cypress Pharmaceutical, Inc., announced today that the U.S. Food and Drug Administration (FDA) has granted final approval of the company's abbreviated new drug application (ANDA) for the prescription Source: www.pharmalive.com Wandashan Pharma injections confirmed as contaminated - Interfax Information Agency China Shanghai. October 15. INTERFAX-CHINA - Samples of a lethal injection manufactured by Heilongjiang Wandashan Pharmaceutical Ltd. contain that some product samples had been contaminated, a joint Ministry of Health (MoH) and State Food and Drug Source: www.interfax.cn Two sides to medical marijuana debate - Detroit Free Press As a family practitioner in a suburban practice, I have some issues with legalizing medical marijuana. Marijuana cigarettes are scheduled "Category 1" by the Drug Enforcement Agency. Ecstasy, quaaludes, LSD and magic mushrooms are also Category 1 Source: www.freep.com Thailand finds melamine in condensed milk, orders recall - Reuters BANGKOK, Oct 15 (Reuters) - Thailand's Food and Drug Administration said on Wednesday tests had found "very high" levels of melamine in a sample of unsweetened condensed milk produced and sold in Thailand. The FDA ordered the maker of Mali Source: www.reuters.com Lumen Biomedical Receives FDA Clearance of Embolectomy System for - Forbes Lumen Biomedical Receives FDA Clearance of Embolectomy System for - Forbes
Lumen Biomedical, Inc., a Minnesota-based medical device company, announced today receipt of FDA clearance for the LBI Embolectomy System for use in the removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature. The LBI Source: www.forbes.com Advaxis Incorporated Provides Complete Response to FDA's Questions - PR Inside www.advaxis.com - The Investor Relations Group 212-825-3210 Investor Relations Conrad F. Mir conrad@investorrelationsgroup.com or Christine Berni christine@investorrelationsgroup.com or Public & Media Relations Janet Vasquez janet Source: www.pr-inside.com Feds may put end to 'enhancement' e-mail - Chicago Sun-Times If you have an e-mail account, you've almost certainly received an offer for a product that promises "male enhancement." You probably ask yourself one of two questions: How did they know? Or, more likely, who would buy this stuff? Legions of Source: www.suntimes.com LabCorp ovarian cancer test sales illegal: FDA - Reuters WASHINGTON (Reuters) - Laboratory Corp of America is violating the law by selling an ovarian cancer screening test without regulatory approval, U.S. health officials said on Wednesday. The OvaSure test does not fall in a category that can be sold Source: www.reuters.com Targanta Announces Review of Oritavancin at FDA Anti-Infective Drugs - MSN MoneyCentral Targanta Therapeutics Corporation TARG announced today that the U.S. Food and Drug Administration's (FDA) Anti-Infective Drugs Advisory Committee will review the Company ’ s New Drug Application (NDA) for oritavancin on November 19, 2008. Targanta Source: news.moneycentral.msn.com Potential Problems at Two Baltimore Pharmacies Potential Problems at Two Baltimore Pharmacies
FDA is warning consumers who filled prescriptions at The Medicine Shoppe pharmacies located at 8035A Liberty Road and 5900 Reisterstown Road in Baltimore that they may have received drugs that were either expired or suspected counterfeit. Infant Formula Manufactured in China Contaminated With Melamine UPDATE - FDA investigation of Asian markets found no Chinese-manufactured infant formula on shelves. FDA 101: Dietary Supplements Part of the "FDA 101" series, this article describes how dietary supplements are regulated and offers safety tips for consumers. Health Information Advisory on Infant Formula In response to reports of contaminated milk-based infant formula manufactured in China, FDA issued a Health Information Advisory on September 12, 2008. Addressing Questions About Gardasil FDA addresses the safety of Gardasil, a vaccine that prevents infection with types of human papillomavirus (HPV) FDA Launches Food Defense Awareness Training Kit for Employees in the Food Industry Today the U.S. Food and Drug Administration in collaboration with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture launched its food defense awareness training kit for first line food industry employees. The training targets these individuals because they can play an important role in helping to keep our nation's food supply safe, from the farm to the table. Warning on Certain Mussel Products from Bantry Bay Seafood FDA is warning consumers against eating certain frozen cooked mussel products made by Bantry Bay Seafoods because they may be contaminated with azaspiracid toxins. Vaccines Stand Ready for Flu Season FDA has approved six vaccines for the 2008-2009 flu season. Recalls and Melamine Contamination FDA has increased inspections and product testing in response to the melamine contamination problem that originated in Chinese dairy products. Draft Guidance on Genetically Engineered Animals The technology of genetic engineering offers many benefits for health, agriculture, and the environment. FDA tells how it is regulating genetically engineered animals. Current Drug Shortage: Proglycem (diazoxide) oral suspension Current Drug Shortage: Proglycem (diazoxide) oral suspension
Teva is managing inventory and can provide product from their emergency supply. Orders for Proglycem can be made during regular business hours (8am to 5pm Eastern, Monday through Friday) by calling Customer Service at 800-545-8800. Emergency requests can be made after hours by calling 800-795-2652 Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection) - updated See information in Related Information section. October 14, 2008Drug Shortages: Drugs to be Discontinued; SecreFlo (porcine secretin for injection, 16 mcg/vial) Drug Shortages: Drugs to be Discontinued; SecreFlo (porcine secretin for injection, 16 mcg/vial)
See Related information section Drug Shortage: MVI Adult Injectable Hospira information updated. Current Drug Shortage: Proglycem (diazoxide) oral suspension Teva is managing inventory and can provide product from their emergency supply. Orders for Proglycem can be made during regular business hours (8am to 5pm Eastern, Monday through Friday) by calling Customer Service at 800-545-8800. Emergency requests can be made after hours by calling 800-795-2652 Drug Shortages: Drugs to be Discontinued; SecreFlo (porcine secretin for injection, 16 mcg/vial) See Web site for additional information Preventing Medical Errors: Potentially Fatal Glucose Monitoring Errors with Icodextrin The Institute for Safe Medication Practices (ISMP) is warning again about the possibility of potentially fatal glucose monitoring errors in patients receiving products that contain other sugars. These include oral xylose, parenterals that contain ma... Drug Shortages: Current Drug Shortages; Methadone Hydrochloride Injection See Web site for additional information on this current drug shortage Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection) - updated See information in Related Information section. Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 See Related information section for updated Letter from Mallinckrodt Drug Shortage: Drug to be Discontinued; Revex (Nalmefene HCl Injection) Baxter has discontinued Revex production. Infant Formula Manufactured in China Contaminated With Melamine UPDATE - FDA investigation of Asian markets found no Chinese-manufactured infant formula on shelves. Ginsing Injection 'Tainted by Bacteria,' Caused 3 Deaths - FOX News Ginsing Injection 'Tainted by Bacteria,' Caused 3 Deaths - FOX News
Tests on samples of a ginsing injection used on heart patients showed the product had been "tainted by bacteria," the State Food and Drug Administration and Ministry of Health said in a statement Tuesday, according to the official Xinhua News Agency Source: www.foxnews.com China blames tainted ginseng injection in 3 deaths - BusinessWeek A ginseng injection contaminated by bacteria caused the deaths of three people using the medicine to treat thrombosis and heart disease, state media reported Tuesday. Tests on samples of an herbal injection showed the product had been "tainted by Source: www.businessweek.com U.S. lawmakers expand probe to Bayer aspirin ads - Reuters WASHINGTON, Oct 14 (Reuters) - U.S. Democratic lawmakers are expanding their probe into direct-to-consumer drug advertisements to include Bayer AG's (BAYG.DE: Quote , Profile , Research , Stock Buzz ) combination aspirin product, according to letters Source: www.reuters.com Infant Formula Manufactured in China Contaminated With Melamine Infant Formula Manufactured in China Contaminated With Melamine
UPDATE - FDA investigation of Asian markets found no Chinese-manufactured infant formula on shelves. FDA Updates Health Information Advisory on Melamine Contamination The U.S. Food and Drug Administration (FDA) is alerting consumers that seven Mr. Brown instant coffee and milk tea products manufactured in China are being recalled by the King Car Food Industrial Co. Ltd. due to possible contamination with melamine. Barry Callebaut USA LLC Issues Allergen Alert on Undeclared Milk Protein in Kroger Value Semi Sweet Chocolate Chips (October 10) Barry Callebaut USA LLC is conducting a voluntary recall on its product sold by Kroger Stores under the brand "Kroger Value Semi Sweet Chocolate Chips", 12 oz., UPC Code is 11110–86603 and "sell by" date May 30, 2010, as the product may contain undeclared milk protein. The "sell by" date is found printed in black on the end of the bag. People with allergies or severe sensitivity to milk protein may be at risk of serious or life-threatening allergic reaction if they consume this product. Bimbo Bakeries USA Issues an Allergy Alert on Undeclared Tree Nuts in Oroweat 100 Percent Whole Wheat Bread Packaging (September 16) Bimbo Bakeries USA today announced a voluntary recall of Oroweat 100 Percent Whole Wheat bread because it may contain tree nuts that are not listed on the label. Individuals with allergies to tree nuts run the risk of a serious and or life threatening reaction if they consume this product. Consumer Alert: Undeclared Sulfites in Shad Raisins (October 6) New York State Agriculture Commissioner alerted consumers that Fatima Brothers Inc. of Maspeth, New York is recalling Shad Raisins due to the presence of undeclared sulfites. The recalled Shad Raisins were packaged in uncoded, 7-ounce plastic bags. Shad Raisins were distributed in New York City. Ammonul (sodium phenylacetate and sodium benzoate) Injection 10%/10% Particulate matter detected in product. Healthcare providers instructed to use a filter during the admixture process. Wegmans Expands Dates of Bagel Recall and Includes Additional Bakery Products (September 11) Wegmans Food Markets, Inc. has expanded the voluntary recall of in-store made bagels and bialys first announced on Wednesday, September 10. The recall is now expanded to include Challah bread and in-store baked bagels, bialys and rolls. These products were sold in Wegmans' bakery department between June 19 and September 11, 2008. Keeping Watch Over Direct-to-Consumer Ads FDA regulates direct-to-consumer advertising for prescription drugs, working to ensure that ads are truthful, balanced, and accurate. Russell Stover Candies, Inc. Issues Hazelnut Allergy Alert for the 2 7/8 Oz Size Of Private Reserve Assorted Chocolates (October 9) The recalled product was distributed in the following states and cities: Texas, California, Louisiana, North Carolina, South Carolina, Virginia, Tennessee; Southaven, Mississippi; Billings, Montana; Sparks, Nevada; and Madison Heights, Michigan. An investigation determined 29 boxes of this candy may have been purchased by consumers, and up to another 188 boxes may have reached retail store locations. All the retail stores have been contacted to have the suspected product removed from the shelves. Fineland Corp Issues Alert on Undeclared Sulfites in Ying Feng Foodstuffs Brand Pumpkin Seeds (September 23) Ying Feng Foodstuffs Brand Pumpkin Seeds is sold in a 10 ounce, clear plastic package with the following code: EXP 03 25 2010 and was distributed nationwide. It is a product of China. Resolved Drug Shortage: Digoxin oral tablets Resolved Drug Shortage: Digoxin oral tablets
See website for more information about this resolved shortage. Drug Shortages: Current Drug Shortages; Phospholine Iodide, Ophthalmic solution See Web site for additional information on this current drug shortage FDA Approves Rapaflo for the Treatment of Symptoms Due to an Enlarged Prostate Gland The U.S. Food and Drug Administration today approved Rapaflo (silodosin) capsules for the treatment of symptoms due to benign prostatic hyperplasia (BPH), a condition also known as an enlarged prostate. Recalls and Safety Alerts: CT Scanning May Cause Malfunction of Electronic Medical Devices FDA is alerting healthcare professionals that the x-rays emitted during CT exams may cause some electronic medical devices to malfunction. These malfunctions are different from those related to MRI scanning, which are caused by strong electrical and... Preventing Medical Errors: Potentially Fatal Glucose Monitoring Errors with Icodextrin The Institute for Safe Medication Practices (ISMP) is warning again about the possibility of potentially fatal glucose monitoring errors in patients receiving products that contain other sugars. These include oral xylose, parenterals that contain ma... October 13, 2008Recalls and Safety Alerts: Avoiding Cardiotoxicity with Mitoxantrone Recalls and Safety Alerts: Avoiding Cardiotoxicity with Mitoxantrone
FDA is reemphasizing the importance of monitoring cardiac function in patients treated with mitozantrone, sold as Novantrone and also as a generic. Mitozantrone is used to treat certain patients with prostate cancer, leukemia and multiple sclerosis ... Ammonul (sodium phenylacetate and sodium benzoate) Injection 10%/10% Particulate matter detected in product. Healthcare providers instructed to use a filter during the admixture process. FDA Approves Use of Temporary Pump to Assist Heart's Right Side The U.S. Food and Drug Administration approved a Humanitarian Device Exemption (HDE) for the first heart pump that provides certain critically ill patients with temporary support for the right side of their heart. Heart assist devices are mechanical pumps that aid in the pumping action of a weakened heart. Most heart assist devices support the heart's left ventricle, which pumps oxygen-rich blood to the rest of the body. The CentriMag Right Ventricular Assist System is intended for patients requiring support for the heart's right ventricle, which passes oxygen-depleted blood to the lungs to be refreshed with oxygen. Recalls and Safety Alerts: Update on Cardiopulmonary Reactions with Ultrasound Micro-bubble Contrast Agents FDA is alerting healthcare professionals about labeling changes for ultrasound micro-bubble contrast agents, which are sold as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injec... FDA Launches Food Defense Awareness Training Kit for Employees in the Food Industry Today the U.S. Food and Drug Administration in collaboration with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture launched its food defense awareness training kit for first line food industry employees. The training targets these individuals because they can play an important role in helping to keep our nation's food supply safe, from the farm to the table. FDA Approves Rapaflo for the Treatment of Symptoms Due to an Enlarged Prostate Gland The U.S. Food and Drug Administration today approved Rapaflo (silodosin) capsules for the treatment of symptoms due to benign prostatic hyperplasia (BPH), a condition also known as an enlarged prostate. Preventing Medical Errors: Potentially Fatal Glucose Monitoring Errors with Icodextrin The Institute for Safe Medication Practices (ISMP) is warning again about the possibility of potentially fatal glucose monitoring errors in patients receiving products that contain other sugars. These include oral xylose, parenterals that contain ma... FDA Statement Following CHPA's Announcement on Nonprescription Over-the-Counter Cough and Cold Medicines in Children The steps that are being taken by CHPA will not affect the availability of the medicines, but this voluntary action will result in a transition period where the instructions for use of some OTC cough and cold medicines in children will be different from others. FDA does not typically request removal of OTC products with previous labeling from the shelves during a voluntary label change such as this one. Therefore, some medicines will have the new recommendation "do not use" for children under 4 years of age, while others will instruct that they not be used for children under 2 years of age. If parents or caregivers have or purchase a product that does not have the voluntarily-modified labeling, FDA recommends that they should adhere to the dosage instructions and warnings on the label that accompanies the medication. They should not, under any circumstances, give adult medications to children. If parents or caregivers have questions or are just not sure about how to use a product, they should consult with their doctor or pharmacist. FDA Approves Rapaflo for the Treatment of Symptoms Due to an Enlarged Prostate Gland FDA Approves Rapaflo for the Treatment of Symptoms Due to an Enlarged Prostate Gland
The U.S. Food and Drug Administration today approved Rapaflo (silodosin) capsules for the treatment of symptoms due to benign prostatic hyperplasia (BPH), a condition also known as an enlarged prostate. FDA Updates Health Information Advisory on Melamine Contamination The U.S. Food and Drug Administration (FDA) is alerting consumers that seven Mr. Brown instant coffee and milk tea products manufactured in China are being recalled by the King Car Food Industrial Co. Ltd. due to possible contamination with melamine. Mr. Brown 3-In-1 and and 2-In-1 Powdered Packets in Bag Coffee Mixes Due To Health Risk (October 1) The recall was initiated after the manufacturer notified Sunny Maid that these 3-in-1 and 2-in-1 Coffee Mix products may contain melamine. Although only certain lots are potentially contaminated, Sunny Maid is recalling all lots. No illnesses associated with this product have been reported to date. Consumer Alert: Possible Botulism Contamination in Frozen Salted Croaker (October 6) New York State Agriculture Commissioner alerted consumers not to eat Frozen Salted Croaker distributed by YS Trading Corp, Long Island City, New York because the product was uneviscerated. The Frozen Salted Croaker was sold in Hicksville, New York, Flushing, New York, and New Jersey in un-coded, unlabeled plastic bags. Bimbo Bakeries USA Issues an Allergy Alert on Undeclared Tree Nuts in Oroweat 100 Percent Whole Wheat Bread Packaging (September 16) Bimbo Bakeries USA today announced a voluntary recall of Oroweat 100 Percent Whole Wheat bread because it may contain tree nuts that are not listed on the label. Individuals with allergies to tree nuts run the risk of a serious and or life threatening reaction if they consume this product. FDA Issues Health Information Advisory on Infant Formula In response to reports of contaminated milk-based infant formula manufactured in China, the U.S. Food and Drug Administration (FDA) today is issuing a Health Information Advisory. This is to assure the American public that there is no known threat of contamination in infant formula manufactured by companies that have met the requirements to sell infant formula in the United States. Although no Chinese manufacturers of infant formula have fulfilled the requirements to sell infant formula in the United States, FDA officials are investigating whether or not infant formula manufactured in China is being sold in specialty markets which serve the Asian community. Neurobiological Technologies plans to consolidate two Phase 3 trials - RTT News Neurobiological Technologies plans to consolidate two Phase 3 trials - RTT News
(RTTNews) - Neurobiological Technologies, Inc. (NTII: News ) said Monday that subsequent to the discussions with the U.S Food and Drug Administration, or FDA, regarding the Viprinex Phase 3 clinical program for acute ischemic stroke, the company Source: www.rttnews.com What raw milk and the economic meltdown have in common - San Francisco Gate Monday, October 13, 2008 Collateralized debt obligations based on subprime mortgages have brought America's economy to its knees. In China, dairy tainted with melamine was used to make infant formula that is now blamed for sickening 53,000 infants Source: www.sfgate.com Ahead of the Bell: Analysts stay bullish on PPD - Forbes Analysts remained bullish on Pharmaceutical Product Development Inc. Monday despite an expected delay in a $25 million payment from partner Takeda Pharmaceuticals, saying PPD is in a strong long-term position within the drug development services Source: www.forbes.com Limit on cold remedies for kids was FDA’s idea - WNYT (AP) WASHINGTON - When drug makers made a surprise announcement this week that they no longer recommend cough and cold remedies for youngsters under 4, they didn’t let on that it was the government’s idea. And why age 4 rather than the age 6 that Source: wnyt.com OncoGenex Achieves Key Regulatory Milestone for Lead Product Candidate - Forbes FDA confirms appropriateness of durable pain palliation as a primary endpoint for product marketing approval Milestone achievement results in release of escrowed shares BOTHELL, WA and VANCOUVER, Oct. 13 /PRNewswire-FirstCall/ - OncoGenex Source: www.forbes.com FDA Approves Use of Temporary Pump to Assist Heart's Right Side FDA Approves Use of Temporary Pump to Assist Heart's Right Side
The U.S. Food and Drug Administration approved a Humanitarian Device Exemption (HDE) for the first heart pump that provides certain critically ill patients with temporary support for the right side of their heart. Heart assist devices are mechanical pumps that aid in the pumping action of a weakened heart. Most heart assist devices support the heart's left ventricle, which pumps oxygen-rich blood to the rest of the body. The CentriMag Right Ventricular Assist System is intended for patients requiring support for the heart's right ventricle, which passes oxygen-depleted blood to the lungs to be refreshed with oxygen. FDA Detects Melamine Contamination in Flavored Drink FDA Detects Melamine Contamination in Flavored Drink
The U.S. Food and Drug Administration (FDA) has increased inspections and product testing efforts in response to the melamine contamination problem which originated in Chinese dairy products. As a result of the FDA's on-going testing program, the agency has detected melamine contamination in Blue Cat Flavor Drinks. The distributor of the product, Tristar Food Wholesale Co. Inc., initiated a recall of several flavors of Blue Cat Flavor Drink, based on the FDA’s findings. The FDA advises the public not to consume this product and recommends that retailers and food service operators remove the product from sale or service. FDA Updates Health Information Advisory on Melamine Contamination The U.S. Food and Drug Administration (FDA) is alerting consumers that seven Mr. Brown instant coffee and milk tea products manufactured in China are being recalled by the King Car Food Industrial Co. Ltd. due to possible contamination with melamine. Addressing Questions About Gardasil FDA addresses the safety of Gardasil, a vaccine that prevents infection with types of human papillomavirus (HPV) CaJohns Fiery Foods Company Recalls HDH Grillin' Sauce (September 24) CaJohns Fiery Foods Company is recalling a total of 103 individual bottles of HDH Grillin' Sauce sold between the dates of 01/01/07 and 09/15/08. This recall is initiated due to the possibility of non-declared contents on the Ingredient Declaration. The products contain the listed Worcestershire Sauce, but may not be parenthetically listed as to it's ingredients one of which is Anchovies, a serious allergen to specific individuals. These products also contain the listed Soy Sauce, but may not be parenthetically listed as to it's ingredients. Soy Sauce contains Soybeans and Wheat which are serious allergens to specific individuals. FDA Issues Health Information Advisory on Infant Formula In response to reports of contaminated milk-based infant formula manufactured in China, the U.S. Food and Drug Administration (FDA) today is issuing a Health Information Advisory. This is to assure the American public that there is no known threat of contamination in infant formula manufactured by companies that have met the requirements to sell infant formula in the United States. Although no Chinese manufacturers of infant formula have fulfilled the requirements to sell infant formula in the United States, FDA officials are investigating whether or not infant formula manufactured in China is being sold in specialty markets which serve the Asian community. Arnold Foods Company, Inc. Issues Allergy Alert on Undeclared Nuts in Brownberry Whole Grains Bread 100 Percent Whole Wheat (October 8) The product being recalled has a green twist tie with a code date of "Oct 11" printed on the bread bag. No other Arnold brand or Brownberry brand products are affected. Recalls and Melamine Contamination FDA has increased inspections and product testing in response to the melamine contamination problem that originated in Chinese dairy products. Consumer Alert: Undeclared Sulfites in Shad Raisins (October 6) New York State Agriculture Commissioner alerted consumers that Fatima Brothers Inc. of Maspeth, New York is recalling Shad Raisins due to the presence of undeclared sulfites. The recalled Shad Raisins were packaged in uncoded, 7-ounce plastic bags. Shad Raisins were distributed in New York City. Draft Guidance on Genetically Engineered Animals The technology of genetic engineering offers many benefits for health, agriculture, and the environment. FDA tells how it is regulating genetically engineered animals. Recall of Patak's Dopiaza Cooking Sauce (September 4) ACH Food Companies, Inc. is recalling its Patak's Dopiaza Cooking Sauce sold in the United States because it may contain an undeclared milk allergen. People who have an allergy or severe sensitivity to milk may run the risk of serious or life-threatening allergic reaction if they consume these products. The product is distributed nationally through retail stores. ACH Food Companies is notifying its distributors and stores that carry this product that it contains an undeclared milk allergen and to immediately remove it from distribution. October 12, 2008Consumer Alert: Possible Botulism Contamination in Frozen Salted Croaker (October 6) Consumer Alert: Possible Botulism Contamination in Frozen Salted Croaker (October 6)
New York State Agriculture Commissioner alerted consumers not to eat Frozen Salted Croaker distributed by YS Trading Corp, Long Island City, New York because the product was uneviscerated. The Frozen Salted Croaker was sold in Hicksville, New York, Flushing, New York, and New Jersey in un-coded, unlabeled plastic bags. FDA Detects Melamine Contamination in Flavored Drink - WebWire FDA Detects Melamine Contamination in Flavored Drink - WebWire
The U.S. Food and Drug Administration (FDA) has increased inspections and product testing efforts in response to the melamine contamination problem which originated in Chinese dairy products. As a result of the FDA’s on-going testing program, the Source: www.webwire.com FDA: Traces of melamine are not harmful in foods - Detroit News WASHINGTON -- Tiny traces of melamine, the chemical that has set off a global food safety scare, are not harmful in most foods, except baby formula, government experts said Friday. The Food and Drug Administration said Friday its safety experts have Source: www.detnews.com BRIEF-MedX Health wins FDA clearance for Oralase - Forbes Copyright Thomson Financial News Limited 2007. All rights reserved. The copying, republication or redistribution of Thomson Financial News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Source: www.forbes.com FDA: Melamine unacceptable - Morris County Daily Record No level of the chemical melamine, which has been found in milk from China, is acceptable in baby formula, the Food and Drug Administration has ruled. In other foods, only a tiny amount -- 2.5 parts per million -- is considered acceptable, the agency Source: www.dailyrecord.com Tarceva (erlotinib) Tarceva (erlotinib)
Cases of hepatic failure and hepatorenal syndrome, including fatalities, have been reported during use of Tarceva, particularly in patients with baseline hepatic impairment. Arnold Foods Company, Inc. Issues Allergy Alert on Undeclared Nuts in Brownberry Whole Grains Bread 100 Percent Whole Wheat (October 8) The product being recalled has a green twist tie with a code date of "Oct 11" printed on the bread bag. No other Arnold brand or Brownberry brand products are affected. Ammonul (sodium phenylacetate and sodium benzoate) Injection 10%/10% Particulate matter detected in product. Healthcare providers instructed to use a filter during the admixture process. CaJohns Fiery Foods Company Recalls HDH Grillin' Sauce (September 24) CaJohns Fiery Foods Company is recalling a total of 103 individual bottles of HDH Grillin' Sauce sold between the dates of 01/01/07 and 09/15/08. This recall is initiated due to the possibility of non-declared contents on the Ingredient Declaration. The products contain the listed Worcestershire Sauce, but may not be parenthetically listed as to it's ingredients one of which is Anchovies, a serious allergen to specific individuals. These products also contain the listed Soy Sauce, but may not be parenthetically listed as to it's ingredients. Soy Sauce contains Soybeans and Wheat which are serious allergens to specific individuals. Ralston Foods Issues Allergy Alert For Undeclared Milk Ingredients In Western Family Variety Pack Instant Oatmeal (September 15) Ralston Foods, Division of Ralcorp Holdings, Inc. is recalling 14664 cartons of Western Family Variety Pack Instant Oatmeal cereal bearing the "Best If Used By" Date Code of "DEC0409N" (found on the box top) because a small number of cartons contain an undeclared milk ingredient. FDA Issues Health Information Advisory on Infant Formula In response to reports of contaminated milk-based infant formula manufactured in China, the U.S. Food and Drug Administration (FDA) today is issuing a Health Information Advisory. This is to assure the American public that there is no known threat of contamination in infant formula manufactured by companies that have met the requirements to sell infant formula in the United States. Although no Chinese manufacturers of infant formula have fulfilled the requirements to sell infant formula in the United States, FDA officials are investigating whether or not infant formula manufactured in China is being sold in specialty markets which serve the Asian community. McCormick and Company Has Recalled McCormick Enchilada Sauce Mix Due To Unlabeled Milk Ingredients (September 30) The McCormick Enchilada Sauce Mix was distributed to grocery stores nationally beginning on September 17, 2008. The product comes in 1.5 oz. pouches with an expiration date of "best by" AUG2910CH. The date is found printed in black on the back, bottom left of the pouch. Epoetin alfa Preliminary safety findings from a German clinical trial showed more deaths in patients given epoetin-alpha versus placebo. Fineland Corp Issues Alert on Undeclared Sulfites in Ying Feng Foodstuffs Brand Pumpkin Seeds (September 23) Ying Feng Foodstuffs Brand Pumpkin Seeds is sold in a 10 ounce, clear plastic package with the following code: EXP 03 25 2010 and was distributed nationwide. It is a product of China. FDA Updates Health Information Advisory on Melamine Contamination The U.S. Food and Drug Administration (FDA) is alerting consumers that seven Mr. Brown instant coffee and milk tea products manufactured in China are being recalled by the King Car Food Industrial Co. Ltd. due to possible contamination with melamine. FDA Law Enforcers Crack Down on Illegal Botox Scammer FDA Law Enforcers Crack Down on Illegal Botox Scammer
FDA's Office of Criminal Investigations found physicians who put profit before patients when they injected them with fake Botox Cosmetic. Addressing Questions About Gardasil FDA addresses the safety of Gardasil, a vaccine that prevents infection with types of human papillomavirus (HPV) Ammonul (sodium phenylacetate and sodium benzoate) Injection 10%/10% Particulate matter detected in product. Healthcare providers instructed to use a filter during the admixture process. Bottled Water Everywhere: Keeping it Safe Americans drink billions of gallons of bottled water each year. Find out about FDA's role in ensuring that bottled water products are safe. Outsmarting Poison Ivy and Other Poisonous Plants Poison ivy and other poisonous plants are a hazard all year round. Here are tips for preventing and treating the itchy rash and blisters. Recalls and Melamine Contamination FDA has increased inspections and product testing in response to the melamine contamination problem that originated in Chinese dairy products. Nebion HLX-8 Magnetic Resonance Device Device recalled because it was not approved by FDA, lacked safety and effectiveness data, and was not manufactured under current good manufacturing practices. Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243
See Web site for additional information on this current drug shortage FDA Issues Health Information Advisory on Infant Formula In response to reports of contaminated milk-based infant formula manufactured in China, the U.S. Food and Drug Administration (FDA) today is issuing a Health Information Advisory. This is to assure the American public that there is no known threat of contamination in infant formula manufactured by companies that have met the requirements to sell infant formula in the United States. Although no Chinese manufacturers of infant formula have fulfilled the requirements to sell infant formula in the United States, FDA officials are investigating whether or not infant formula manufactured in China is being sold in specialty markets which serve the Asian community. |
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