August 16, 2008FDA Warns Consumers About Potential Problems at Two Baltimore Pharmacies FDA Warns Consumers About Potential Problems at Two Baltimore Pharmacies
The U.S. Food and Drug Administration 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. The FDA is particularly concerned because a number of the drugs are for serious diseases and could have an adverse effect on treatment. Erythropoiesis Stimulating Agents (ESAs) - Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp) UPDATE - Dear Healthcare Professional letter added. Boston Scientific NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System Product recalled because the tip of the stent delivery system may detach during a carotid artery stenting procedure. New England Journal Editors File Brief Against Wyeth (Update3) - Bloomberg New England Journal Editors File Brief Against Wyeth (Update3) - Bloomberg
Aug. 15 (Bloomberg) -- Consumers should be allowed to sue drugmakers for failing to warn of dangers even if prescribing literature for a drug was approved by regulators, six current and former editors of the New England Journal of Medicine said in a Source: www.bloomberg.com FDA Downplays Risk of BPA - Washington Post A controversial chemical commonly found in can linings, baby bottles and other household products does not pose a health hazard when used in food containers, according to a draft assessment released by the Food and Drug Administration yesterday. The Source: www.washingtonpost.com Top medical journal advises Supreme Court not to bar lawsuits over FDA - Newsday WASHINGTON (AP) _ Top doctors at the helm of one of the nation's most influential medical journals are giving the Supreme Court some unsolicited legal advice about a major case. The Food and Drug Administration "is in no position" to guarantee drug Source: www.newsday.com Quitting smoking? Drug edges nicotine patch - MSNBC NEW YORK - The anti-smoking drug Chantix appears more effective than the nicotine patch in helping people stop smoking, European and U.S. researchers report. In a study of 746 smokers, the investigators found that 56 percent of those who took for Source: www.msnbc.msn.com Salmonella outbreak winds down; questions remain - Miami Herald The nationwide salmonella outbreak is finally winding down but federal health officials can't yet say how the few tainted Mexican peppers they've found could explain such widespread illness. The outbreak isn't considered over yet, Food and Drug Source: www.miamiherald.com FDA says chemical found in plastic bottles is safe - Chicago Sun-Times WASHINGTON -- Despite ongoing safety concerns from parents, consumer groups and politicians, a chemical used in baby bottles, canned food and other items is not dangerous, federal regulators said Friday. Food and Drug Administration scientists said Source: www.suntimes.com FDA concludes bisphenol A chemical used in baby bottles, canned food - Minneapolis Star Tribune WASHINGTON - Despite ongoing safety concerns from parents, consumer groups and politicians, a chemical used in baby bottles, canned food and other items is not dangerous, federal regulators said Friday. Food and Drug Administration scientists said Source: www.startribune.com First U.S. drug for Huntington’s approved - MSNBC WASHINGTON - Federal regulators on Friday cleared the first treatment approved in the United States for Huntington’s, a rare inherited disease that causes uncontrolled movements, deterioration of mental abilities and, ultimately, death. The Source: www.msnbc.msn.com FDA to hold meeting on baby bottle chemical - Reuters WASHINGTON (Reuters) - The U.S. Food and Drug Administration said on Friday it will hold a public meeting next month about the safety of a chemical found in baby bottles and many other products. Environmental groups say the chemical, bisphenol A, can Source: www.reuters.com Lawsuits help guarantee drug safety, doctors say - San Francisco Gate Top doctors at the helm of one of the nation's most influential medical journals are giving the Supreme Court some unsolicited legal advice about a major case. The Food and Drug Administration "is in no position" to guarantee drug safety, the editors Source: www.sfgate.com FDA says chemical found in plastic bottles is safe - Chicago Sun-Times FDA says chemical found in plastic bottles is safe - Chicago Sun-Times
WASHINGTON -- Despite ongoing safety concerns from parents, consumer groups and politicians, a chemical used in baby bottles, canned food and other items is not dangerous, federal regulators said Friday. Food and Drug Administration scientists said Source: www.suntimes.com FDA approves 1st therapy to help ease Huntington's - Reuters WASHINGTON (Reuters) - U.S. health officials have approved the first drug aimed at easing symptoms of Huntington's disease, an incurable neurological disorder that can cause uncontrollable movements. The drug, called Xenazine, does not treat the Source: www.reuters.com Customers say company’s vitamins made them sick - Atlanta Journal Constitution Over the years, a Woodstock company’s fruit-flavored vitamin supplement gained a loyal following. Customers swore it made them healthier and their testimonials persuaded friends and family to take it, too. They never imagined it would be the cause Source: www.ajc.com FDA Downplays Risk of BPA - Washington Post FDA Downplays Risk of BPA - Washington Post
A controversial chemical commonly found in can linings, baby bottles and other household products does not pose a health hazard when used in food containers, according to a draft assessment released by the Food and Drug Administration yesterday. The Source: www.washingtonpost.com FDA Approves Prestwick's Drug for Huntington Disease - Eflux Media The Food and Drug Administration (FDA) on Friday approved tetrabenazine, marketed by Prestwick Pharmaceuticals under the Xenazine brand name, for the treatment of hyperkinetic movement disorder associated with Huntington disease, being the first Source: www.efluxmedia.com FDA Draft Report: No Risk From BPA In Food Containers - Washington Post Some stores are stocking water bottles that do not contain bisphenol A (BPA), one of the most widely used synthetic chemicals. (By David Mcnew -- Getty Images) A controversial chemical commonly found in can linings, baby bottles and other household Source: www.washingtonpost.com FDA: Chemicals in Plastic Bottles Safe - LiveScience.com WASHINGTON (AP) _ Despite ongoing safety concerns from parents, consumer groups and politicians, a chemical used in baby bottles, canned food and other items is not dangerous, federal regulators said Friday. Food and Drug Administration scientists Source: www.livescience.com Expected FDA approvals draw backers to ProStrakan - Sunday Herald GALASHIELS DRUGS group ProStrakan has made an early bid to become Scotland's share of the year following a wave of support from investors buying into the company in anticipation of an early breakthrough into the lucrative US market. One wealthy buyer Source: www.sundayherald.com Salmonella outbreak winding down but FDA probe can't yet explain the - Newsday WASHINGTON (AP) _ The nationwide salmonella outbreak is finally winding down but federal health officials can't yet say how the few tainted Mexican peppers they've found could explain such widespread illness. The outbreak isn't considered over yet Source: www.newsday.com FDA: Controversial chemical in plastics is safe - CNN WASHINGTON (AP) -- Despite ongoing safety concerns from parents, consumer groups and politicians, a chemical used in baby bottles, canned food and other items is not dangerous, federal regulators said Friday. Nalgene brand water bottles are made with Source: www.cnn.com Customer’s say Georgia company’s vitamins made them sick - Atlanta Journal Constitution Over the years, a Woodstock company’s fruit-flavored vitamin supplement gained a loyal following. Customers swore it made them healthier and their testimonials persuaded friends and family to take it, too. They never imagined it would be the cause Source: www.ajc.com Top medical journal advises Supreme Court not to bar lawsuits over FDA - Newsday Top medical journal advises Supreme Court not to bar lawsuits over FDA - Newsday
WASHINGTON (AP) _ Top doctors at the helm of one of the nation's most influential medical journals are giving the Supreme Court some unsolicited legal advice about a major case. The Food and Drug Administration "is in no position" to guarantee drug Source: www.newsday.com FDA says chemical found in plastic bottles is safe - Chicago Sun-Times WASHINGTON -- Despite ongoing safety concerns from parents, consumer groups and politicians, a chemical used in baby bottles, canned food and other items is not dangerous, federal regulators said Friday. Food and Drug Administration scientists said Source: www.suntimes.com Quitting smoking? Drug edges nicotine patch - MSNBC NEW YORK - The anti-smoking drug Chantix appears more effective than the nicotine patch in helping people stop smoking, European and U.S. researchers report. In a study of 746 smokers, the investigators found that 56 percent of those who took for Source: www.msnbc.msn.com First U.S. drug for Huntington’s approved - MSNBC WASHINGTON - Federal regulators on Friday cleared the first treatment approved in the United States for Huntington’s, a rare inherited disease that causes uncontrolled movements, deterioration of mental abilities and, ultimately, death. The Source: www.msnbc.msn.com New England Journal Editors File Brief Against Wyeth (Update3) - Bloomberg Aug. 15 (Bloomberg) -- Consumers should be allowed to sue drugmakers for failing to warn of dangers even if prescribing literature for a drug was approved by regulators, six current and former editors of the New England Journal of Medicine said in a Source: www.bloomberg.com FDA Downplays Risk of BPA - Washington Post A controversial chemical commonly found in can linings, baby bottles and other household products does not pose a health hazard when used in food containers, according to a draft assessment released by the Food and Drug Administration yesterday. The Source: www.washingtonpost.com FDA to hold meeting on baby bottle chemical - Reuters WASHINGTON (Reuters) - The U.S. Food and Drug Administration said on Friday it will hold a public meeting next month about the safety of a chemical found in baby bottles and many other products. Environmental groups say the chemical, bisphenol A, can Source: www.reuters.com FDA: Boston Scientific Recalls Neck Artery Stent Products - CNN Money FDA: Boston Scientific Recalls Neck Artery Stent Products - CNN Money
BOSTON -(Dow Jones)- Boston Scientific Corp. (BSX) has recalled products used in procedures to unclog neck arteries due to issues with a stent delivery system, according to the Food and Drug Administration. The agency reported on its Web site Source: money.cnn.com FDA to hold meeting on baby bottle chemical - Reuters WASHINGTON (Reuters) - The U.S. Food and Drug Administration said on Friday it will hold a public meeting next month about the safety of a chemical found in baby bottles and many other products. Environmental groups say the chemical, bisphenol A, can Source: www.reuters.com FDA: Chemical in plastic bottles safe - Detroit News WASHINGTON -- Despite ongoing safety concerns from parents, consumer groups and politicians, a chemical used in baby bottles, canned food and other items is not dangerous, federal regulators said Friday. Food and Drug Administration scientists said Source: www.detnews.com Salmonella outbreak winding down but FDA probe can't yet explain the - Newsday WASHINGTON (AP) _ The nationwide salmonella outbreak is finally winding down but federal health officials can't yet say how the few tainted Mexican peppers they've found could explain such widespread illness. The outbreak isn't considered over yet Source: www.newsday.com Kids face greater risks - Manila Times Govts, cancer and pediatrics societies, World Health Organization don’t warn against mobile phones. But more doctors now urge caution The debate about the seriousness of risks posed by cell phones suddenly became less subdued than it had been for Source: www.manilatimes.net FDA Warns Consumers About Potential Problems at Two Baltimore Pharmacies FDA Warns Consumers About Potential Problems at Two Baltimore Pharmacies
The U.S. Food and Drug Administration 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. The FDA is particularly concerned because a number of the drugs are for serious diseases and could have an adverse effect on treatment. Whole Foods Market Issues Recall on 365 Organic Everyday Value Popcorn, Lightly Salted Due to Undeclared Dairy Allergen (August 14) This product was distributed to and sold in Whole Foods Market retail stores in California, Arizona, Nevada, Kentucky, Maryland, Ohio, Pennsylvania, Virginia, Washington D.C, Connecticut, Maine, Massachusetts, Rhode Island, Oregon, New Jersey, New York and Washington. FDA Extends Consumer Warning on Serrano Peppers from Mexico Laboratory testing by the U.S. Food and Drug Administration has confirmed that both a sample of serrano pepper and a sample of irrigation water collected by agency investigators on a farm in the state of Nuevo Leon, Mexico, contain Salmonella Saintpaul with the same genetic fingerprint as the strain of bacteria that is causing the current outbreak in the United States. Sau-Sea Foods, Inc. Issues Allergy Alert on Undeclared Egg in Smoked Salmon Spread in 7.5 Ounce Plastic Tub With Snap Lid (July 18) Sau-Sea foods, Inc, of Water Mill NY is recalling all tubs of SMOKED SALMON Spread with the sell by dates as follows: 072308, 082708, 092408, 1 12508, 03 1309. People who have an allergy or severe sensitivity to egg run the risk of serious or life threatening allergic reaction if they consume these products. Preventing Medical Errors: Potential Problems with Insulin Pens in Hospitals In a recent article, the Institute for Safe Medication Practices (ISMP) highlighted several potential safety problems when hospitals switch from multiple dose vials of insulin to insulin pens. ISMP points out that there are certain safety advant... FDA Warns Consumers Not to Eat Certain Mussel Products from Bantry Bay Seafood (August 15) The U.S. Food and Drug Administration (FDA) is warning consumers against eating certain frozen cooked mussel products made by Bantry Bay Seafoods, imported from Ireland, because they may be contaminated with azaspiracid toxins, a group of naturally occurring marine toxins known to cause nausea, vomiting, diarrhea, and stomach cramps. Peppers Unlimited, Inc. Recalls La Torre Jalapeno Nacho Slices (August 14) Peppers Unlimited, Inc. of Fontana California is voluntarily recalling 580 cases of La Torre Jalapeno Nacho Slices because of possible product contamination caused by a chemical reaction between the product and the can potentially resulting in a swollen and/or ruptured container and significant off flavor. Home Made Brand Foods Recalls Tuna Salad Because of Possible Health Risk (August 11) Home Made Brand Foods is voluntarily recalling approximately 4890 pounds of Ready-to-Eat Tuna Salad with an expiration date of 8/19/08. This product has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Domega International Co., Ltd. Issues an Alert on Undeclared Sulfites in Korica Brand Mut Gung Sweetened Ginger (July 16) The recalled Korica Brand Mut Gung Sweetened Ginger is sold in uncoded 7 oz plastic tubs and is a product of Vietnam. The product was sold nationwide. EG Labs Announces Urgent Nationwide Voluntary Recall of ALL LOTS of Viapro 375 mg Capsules, due to a Potentially Harmful Ingredient EG Labs, LLC, announced today that it is conducting a nationwide voluntary recall of all lots of its supplement product sold under the brand name, Viapro, in 375mg capsules. EG Labs, LLC. is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of a sample from one lot of the product revealed that it contained a potentially harmful undeclared ingredient, thio-methisosildenafil. New England Journal Editors File Brief Against Wyeth (Update3) - Bloomberg New England Journal Editors File Brief Against Wyeth (Update3) - Bloomberg
Aug. 15 (Bloomberg) -- Consumers should be allowed to sue drugmakers for failing to warn of dangers even if prescribing literature for a drug was approved by regulators, six current and former editors of the New England Journal of Medicine said in a Source: www.bloomberg.com FDA concludes bisphenol A chemical used in baby bottles, canned food - Minneapolis Star Tribune WASHINGTON - Despite ongoing safety concerns from parents, consumer groups and politicians, a chemical used in baby bottles, canned food and other items is not dangerous, federal regulators said Friday. Food and Drug Administration scientists said Source: www.startribune.com FDA approves 1st therapy to help ease Huntington's - Reuters FDA approves 1st therapy to help ease Huntington's - Reuters
WASHINGTON (Reuters) - U.S. health officials have approved the first drug aimed at easing symptoms of Huntington's disease, an incurable neurological disorder that can cause uncontrollable movements. The drug, called Xenazine, does not treat the Source: www.reuters.com Salmonella outbreak winding down but FDA probe can't yet explain the - Newsday WASHINGTON (AP) _ The nationwide salmonella outbreak is finally winding down but federal health officials can't yet say how the few tainted Mexican peppers they've found could explain such widespread illness. The outbreak isn't considered over yet Source: www.newsday.com Medication does not cure the fatal inherited disease, but treats a - Los Angeles Times WASHINGTON (AP) _ Federal regulators on Friday cleared the first treatment approved in the United States for Huntington's, a rare inherited disease that causes uncontrolled movements, deterioration of mental abilities and, ultimately, death. The Source: www.latimes.com FDA says chemical found in plastic bottles is safe - Chicago Sun-Times WASHINGTON -- Despite ongoing safety concerns from parents, consumer groups and politicians, a chemical used in baby bottles, canned food and other items is not dangerous, federal regulators said Friday. Food and Drug Administration scientists said Source: www.suntimes.com Top medical journal advises Supreme Court not to bar lawsuits over FDA - Minneapolis Star Tribune WASHINGTON - Top doctors at the helm of one of the nation's most influential medical journals are giving the Supreme Court some unsolicited legal advice about a major case. The Food and Drug Administration "is in no position" to guarantee drug safety Source: www.startribune.com Salmonella outbreak winds down; questions remain - Miami Herald Salmonella outbreak winds down; questions remain - Miami Herald
The nationwide salmonella outbreak is finally winding down but federal health officials can't yet say how the few tainted Mexican peppers they've found could explain such widespread illness. The outbreak isn't considered over yet, Food and Drug Source: www.miamiherald.com Lawsuits help guarantee drug safety, doctors say - San Francisco Gate Top doctors at the helm of one of the nation's most influential medical journals are giving the Supreme Court some unsolicited legal advice about a major case. The Food and Drug Administration "is in no position" to guarantee drug safety, the editors Source: www.sfgate.com First U.S. drug for Huntington’s approved - MSNBC WASHINGTON - Federal regulators on Friday cleared the first treatment approved in the United States for Huntington’s, a rare inherited disease that causes uncontrolled movements, deterioration of mental abilities and, ultimately, death. The Source: www.msnbc.msn.com FDA says chemical found in plastic bottles is safe - Chicago Sun-Times WASHINGTON -- Despite ongoing safety concerns from parents, consumer groups and politicians, a chemical used in baby bottles, canned food and other items is not dangerous, federal regulators said Friday. Food and Drug Administration scientists said Source: www.suntimes.com States say judgment against Wyeth should be upheld - Forbes Vermont and 46 states are urging the U.S. Supreme Court to uphold a Vermont Supreme Court ruling that forced a drug manufacturer to pay $6.8 million to a woman whose arm had to be amputated after she was injected with one of its medications. A jury Source: www.forbes.com August 15, 2008FDA concludes bisphenol A chemical used in baby bottles, canned food - Minneapolis Star Tribune FDA concludes bisphenol A chemical used in baby bottles, canned food - Minneapolis Star Tribune
WASHINGTON - Despite ongoing safety concerns from parents, consumer groups and politicians, a chemical used in baby bottles, canned food and other items is not dangerous, federal regulators said Friday. Food and Drug Administration scientists said Source: www.startribune.com Salmonella outbreak winds down; questions remain - Miami Herald The nationwide salmonella outbreak is finally winding down but federal health officials can't yet say how the few tainted Mexican peppers they've found could explain such widespread illness. The outbreak isn't considered over yet, Food and Drug Source: www.miamiherald.com Lawsuits help guarantee drug safety, doctors say - San Francisco Gate Top doctors at the helm of one of the nation's most influential medical journals are giving the Supreme Court some unsolicited legal advice about a major case. The Food and Drug Administration "is in no position" to guarantee drug safety, the editors Source: www.sfgate.com Argentina investigates deaths of vaccinated kids - MSNBC BUENOS AIRES, Argentina - Argentine authorities are exploring a possible link between the deaths of 14 children and an experimental vaccine they were taking in a clinical trial run by GlaxoSmithKline. Argentina's food and drug administration is Source: www.msnbc.msn.com First U.S. drug for Huntington’s approved - MSNBC WASHINGTON - Federal regulators on Friday cleared the first treatment approved in the United States for Huntington’s, a rare inherited disease that causes uncontrolled movements, deterioration of mental abilities and, ultimately, death. The Source: www.msnbc.msn.com FDA Downplays Risk of BPA - Washington Post A controversial chemical commonly found in can linings, baby bottles and other household products does not pose a health hazard when used in food containers, according to a draft assessment released by the Food and Drug Administration yesterday. The Source: www.washingtonpost.com Lawsuits help guarantee drug safety, doctors say - San Francisco Gate Lawsuits help guarantee drug safety, doctors say - San Francisco Gate
Top doctors at the helm of one of the nation's most influential medical journals are giving the Supreme Court some unsolicited legal advice about a major case. The Food and Drug Administration "is in no position" to guarantee drug safety, the editors Source: www.sfgate.com Quitting smoking? Drug edges nicotine patch - MSNBC NEW YORK - The anti-smoking drug Chantix appears more effective than the nicotine patch in helping people stop smoking, European and U.S. researchers report. In a study of 746 smokers, the investigators found that 56 percent of those who took for Source: www.msnbc.msn.com Salmonella outbreak winds down; questions remain - Miami Herald The nationwide salmonella outbreak is finally winding down but federal health officials can't yet say how the few tainted Mexican peppers they've found could explain such widespread illness. The outbreak isn't considered over yet, Food and Drug Source: www.miamiherald.com Boston Scientific recalls artery-opening stents - International Herald Tribune WASHINGTON : Medical device maker Boston Scientific Corp. has recalled some of its artery-opening stents due to a defect that can cause part of the devices to break off during surgery. The Food and Drug Administration said Thursday the recall affects Source: www.iht.com FDA concludes bisphenol A chemical used in baby bottles, canned food - Minneapolis Star Tribune WASHINGTON - Despite ongoing safety concerns from parents, consumer groups and politicians, a chemical used in baby bottles, canned food and other items is not dangerous, federal regulators said Friday. Food and Drug Administration scientists said Source: www.startribune.com FDA says chemical found in plastic bottles is safe - Chicago Sun-Times WASHINGTON -- Despite ongoing safety concerns from parents, consumer groups and politicians, a chemical used in baby bottles, canned food and other items is not dangerous, federal regulators said Friday. Food and Drug Administration scientists said Source: www.suntimes.com Actavis Totowa voluntarily recalls drugs - Newsday LITTLE FALLS. N.J. - Actavis Totowa is voluntarily recalling more than 60 generic drugs from hospitals and pharmacies that were manufactured at its Little Falls plant. The Food and Drug Administration earlier this year found the plant did not meet Source: www.newsday.com First U.S. drug for Huntington’s approved - MSNBC WASHINGTON - Federal regulators on Friday cleared the first treatment approved in the United States for Huntington’s, a rare inherited disease that causes uncontrolled movements, deterioration of mental abilities and, ultimately, death. The Source: www.msnbc.msn.com Vita Food Products Issues Alert Regarding Vita Nova Salmon (July 25) Vita Food Products Issues Alert Regarding Vita Nova Salmon (July 25)
The product that is the subject of this public announcement and recall are packages (deep dark blue in color) of smoked salmon that bear the Vita logo in the upper left corner on the part of the packaging that is immediately visible to the consumer. Each package contains 4-10 bacon-style slices (total 3 oz.) of smoked salmon; the slices are contained in a vacuum pack within a box that is 4" wide by 7.5" in length by 1/2" in thickness. IMPORTANT: The Code Date of 11/16/08 198 is on the left end flap of each package. This announcement and recall only applies to packages that bear that CODE DATE. Hop Lee Trading Co., Inc. Issues Alert on Undeclared Sulfites in Flower Brand Dried Sweet Potato (August 12) Hop Lee Trading Co. Inc. is recalling Flower brand Dried Sweet Potato because it contains undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product. Living with Fibromyalgia, Drugs Approved to Manage Pain A second drug has been approved to treat fibromyalgia, a painful chronic condition that affects the muscles and joints. Roxane Laboratories, Inc. Initiates a Nationwide Voluntary Recall of Two Manufacturing Lots of Sodium Polystyrene Sulfonate Suspension in the US and Puerto Rico (July 14) Roxane Laboratories, Inc. announced today that it is conducting a nationwide voluntary recall of two manufacturing lots of Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles (NDC 0054-0165-51; Lot 856396A Exp April 2010, and Lot 856693A Exp May 2010). Pet Food Products Seized at PETCO Distribution Center Consumers who bought animal food products from PETCO in 16 states should take certain precautions 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. Home Made Brand Foods Recalls Tuna Salad Because of Possible Health Risk (August 11) Home Made Brand Foods is voluntarily recalling approximately 4890 pounds of Ready-to-Eat Tuna Salad with an expiration date of 8/19/08. This product has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. EG Labs Announces Urgent Nationwide Voluntary Recall of ALL LOTS of Viapro 375 mg Capsules, due to a Potentially Harmful Ingredient EG Labs, LLC, announced today that it is conducting a nationwide voluntary recall of all lots of its supplement product sold under the brand name, Viapro, in 375mg capsules. EG Labs, LLC. is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of a sample from one lot of the product revealed that it contained a potentially harmful undeclared ingredient, thio-methisosildenafil. FDA Approves First Generic Divalproex Sodium to Treat Seizures, Migraine Headaches and Bipolar Disorder The U.S. Food and Drug Administration today approved the first generic version of Depakote delayed-release tablets (divalproex sodium). Depakote is approved by the FDA for the treatment of seizures, bipolar disorder and migraine headaches. Mars Petcare US Issues Voluntary Recall of Limited Bags of PEDIGREE Complete Nutrition Small Crunchy Bites at Albertsons in Southern California and Las Vegas due to Potential Salmonella Contamination (August 8) Mars Petcare US today announced a voluntary recall of limited bags of PEDIGREE® Complete Nutrition Small Crunchy Bites sold in Albertsons stores in Southern California and Las Vegas, Nevada. The pet food is being voluntarily recalled because of potential contamination with Salmonella. There have been no complaints or reports of injury resulting from consumption or handling of the recalled product. FDA Warns on Alkermes Drug - Street.Com FDA Warns on Alkermes Drug - Street.Com
The Food and Drug Administration warned medical professionals on Tuesday of the risk of adverse reactions at the injection site in patients given alcohol dependence drug naltrexone. Regulators said they received 196 reports of injection site Source: www.thestreet.com FDA warns of reactions to alcohol dependence drug - Reuters WASHINGTON (Reuters) - Nearly 200 patients given Alkermes Inc's drug Vivitrol for alcohol dependence reported complications from the injection, including abscesses requiring surgical drainage, U.S. health regulators said on Tuesday. Vivitrol, an Source: www.reuters.com Vermont and 46 states say Wyeth at fault in Vermont drug case - WCAX MONTPELIER, Vt. (AP) - Vermont and 46 states are urging the U.S. Supreme Court to uphold a Vermont Supreme court ruling that forced a drug manufacturer to pay $6.8 million to a woman whose arm had to be amputated after she was injected with 1 of its Source: www.wcax.com Boston Scientific recalls artery-opening stents - International Herald Tribune WASHINGTON : Medical device maker Boston Scientific Corp. has recalled some of its artery-opening stents due to a defect that can cause part of the devices to break off during surgery. The Food and Drug Administration said Thursday the recall affects Source: www.iht.com FDA warns of skin reactions with alcoholism drug - Boston Globe WASHINGTON— Federal regulators warned doctors Tuesday about severe skin reactions seen in patients taking an injectable treatment for alcoholism made by Alkermes Inc. and marketed by Cephalon Inc. The Food and Drug Administration said physicians Source: www.boston.com FDA warns of reactions to anti-alcohol drug - MSNBC WASHINGTON - Nearly 200 patients given Alkermes Inc’s drug Vivitrol for alcohol dependence reported complications from the injection, including abscesses requiring surgical drainage, U.S. health regulators warned on Tuesday. The Food and Drug Source: www.msnbc.msn.com Actavis Totowa voluntarily recalls drugs - Newsday LITTLE FALLS. N.J. - Actavis Totowa is voluntarily recalling more than 60 generic drugs from hospitals and pharmacies that were manufactured at its Little Falls plant. The Food and Drug Administration earlier this year found the plant did not meet Source: www.newsday.com FDA warns against eating lobster liver - AOL FDA warns against eating lobster liver - AOL
WASHINGTON -The government warned consumers Monday not to eat the soft, green substance found in the body cavity of lobsters, saying it may be contaminated with a toxin. It's still OK to eat the white lobster meat found in the claws and tails of the Source: news.aol.com Santhera's Omigapil Receives Orphan Drug Designation from FDA and EMEA - Phramalive.com LIESTAL,Switzerland, Aug. 15, 2008--Santhera Pharmaceuticals (SWX:SANN), a Swiss specialty pharmaceutical company focused on neuromuscular diseases, announces today that the US Food and Drug Administration (FDA) has granted orphan drug designation to Source: www.pharmalive.com States say judgment against Wyeth should be upheld - Forbes Vermont and 46 states are urging the U.S. Supreme Court to uphold a Vermont Supreme Court ruling that forced a drug manufacturer to pay $6.8 million to a woman whose arm had to be amputated after she was injected with one of its medications. A jury Source: www.forbes.com Insiders Buy Staar as Lasik Alternate Shows Potential (Update1) - Bloomberg Aug. 15 (Bloomberg) -- Staar Surgical Co. insiders and investors are buying stock as they bet the company's $3,081 lens implants to correct nearsightedness will gain on less-costly Lasik treatments, increasing the potential for a takeover. Five Source: www.bloomberg.com Emergency Filtration Products Issues FDA Update - Marketwatch LAS VEGAS, NV, Aug 15, 2008 (MARKET WIRE via COMTEX) -- Emergency Filtration Products, Inc. (EFP) (PINKSHEETS: EMFP) today announced that it recently received a comment letter from the U.S. Food and Drug Administration (FDA) in connection with its Source: www.marketwatch.com Schering Regroups After FDA Rejection - Street.Com OKLAHOMA CITY -- When European regulators approved Schering-Plough's SGP groundbreaking anesthesia drug late last month, investors assumed that the U.S. Food and Drug Administration would bless the drug as well. That turned out to be a mistake. Just Source: www.thestreet.com AHA Comment On FDA Simvastin-Amiodarone Interaction Warning - eMaxHealth.com Health Canada Warns Against Xiadafil VIP Tabs Antibiotics Send Thousands Of Patients To ER FDA Warns About Problems At Two Baltimore Pharmacies The truth on the 8 drugs doctors wouldn't take Ohio State Researchers Explore More Benefits Of Aspirin The Source: www.emaxhealth.com Responsibility of the FDA and National Cancer Institute for Cosmetics - Earthtimes CHICAGO , Aug. 15 /PRNewswire-USNewswire/ -- In November 1994 , the Cancer Prevention Coalition and the Center for Constitutional Rights submitted a Petition to the FDA calling for "Cancer Labeling of Talc Products." Talc products are regularly used Source: www.earthtimes.org FDA clears line of Iridex laser systems - San Jose Business Journal Iridex Corp. said Friday it received clearance from the Food and Drug Administration for its family of laser systems. Mountain View-based Iridex (NASDAQ:IRIX) said the systems are intended for a wide range of applications in the medical specialties Source: sanjose.bizjournals.com IRIDEX Announces FDA Clearance for New Product Family of IRIDEX IQ - MSN MoneyCentral MOUNTAIN VIEW, Calif. , Aug. 15 /PRNewswire-FirstCall/ -- IRIDEX Corporation IRIX announces receipt of FDA 510(k) clearance for its Family of IRIDEX IQ Laser Systems. This clearance covers the IRIDEX IQ 532, IQ 577, IQ 630-670, and IQ 810 Laser Source: news.moneycentral.msn.com Santhera's Omigapil Receives Orphan Drug Designation from FDA and EMEA - Asia Corporate News Network Santhera's Omigapil Receives Orphan Drug Designation from FDA and EMEA - Asia Corporate News Network
Corporate news announcement processed and transmitted by Hugin ASA. The issuer is solely responsible for the content of this announcement. ----- ----- Santhera Pharmaceuticals Source: www.acnnewswire.com IRIDEX (IRIX) Announces FDA Clearance for New IRIDEX IQ Laser Systems - StreetInsider.com IRIDEX Corporation (Nasdaq: IRIX ) announces receipt of FDA 510(k) clearance for its Family of IRIDEX IQ Laser Systems. This clearance covers the IRIDEX IQ 532, IQ 577, IQ 630-670, and IQ 810 Laser Systems and their associated delivery devices to Source: www.streetinsider.com Emergency Filtration Products Issues FDA Update - Market Wire LAS VEGAS, NV--(Marketwire - August 15, 2008) - Emergency Filtration Products, Inc. (EFP) ( PINKSHEETS : EMFP ) today announced that it recently received a comment letter from the U.S. Food and Drug Administration (FDA) in connection with its 510(k Source: www.marketwire.com FDA approves St. Jude treatment for chronic pain - CNN Money NEW YORK (Associated Press) - St. Jude Medical Inc. announced Wednesday that its EonC neurostimulator for chronic pain treatment received U.S. Food and Drug Administration and European CE Mark approvals. The device treats complex neuropathic pain of Source: money.cnn.com Aqua Bounty Technologies says storm damages Central American salmon - Forbes LONDON (Thomson Financial) - Aqua Bounty Technologies Inc. said an unusually severe storm damaged its recently established Central American salmon production unit, which will delay its plans to test market AquAdvantage Salmon. The storm caused the Source: www.forbes.com FDA Grants Full Approval of PROCLEIX(R) ULTRIO(R) Blood Screening - Forbes SAN DIEGO, Aug. 13 /PRNewswire-FirstCall/ -- Gen-Probe Incorporated (Nasdaq: GPRO) announced today that the US Food and Drug Administration (FDA) has approved its supplemental regulatory application to use the PROCLEIX(R) ULTRIO(R) assay to screen Source: www.forbes.com Responsibility of the FDA and National Cancer Institute for Cosmetics - Earthtimes CHICAGO , Aug. 15 /PRNewswire-USNewswire/ -- In November 1994 , the Cancer Prevention Coalition and the Center for Constitutional Rights submitted a Petition to the FDA calling for "Cancer Labeling of Talc Products." Talc products are regularly used Source: www.earthtimes.org Aqua Bounty Technologies says storm damages Central American salmon - Forbes Aqua Bounty Technologies says storm damages Central American salmon - Forbes
LONDON (Thomson Financial) - Aqua Bounty Technologies Inc. said an unusually severe storm damaged its recently established Central American salmon production unit, which will delay its plans to test market AquAdvantage Salmon. The storm caused the Source: www.forbes.com FDA Grants Full Approval of PROCLEIX(R) ULTRIO(R) Blood Screening - Forbes SAN DIEGO, Aug. 13 /PRNewswire-FirstCall/ -- Gen-Probe Incorporated (Nasdaq: GPRO) announced today that the US Food and Drug Administration (FDA) has approved its supplemental regulatory application to use the PROCLEIX(R) ULTRIO(R) assay to screen Source: www.forbes.com IRIDEX (IRIX) Announces FDA Clearance for New IRIDEX IQ Laser Systems - StreetInsider.com IRIDEX Corporation (Nasdaq: IRIX ) announces receipt of FDA 510(k) clearance for its Family of IRIDEX IQ Laser Systems. This clearance covers the IRIDEX IQ 532, IQ 577, IQ 630-670, and IQ 810 Laser Systems and their associated delivery devices to Source: www.streetinsider.com FDA warns of skin reactions with alcoholism drug - Boston Globe FDA warns of skin reactions with alcoholism drug - Boston Globe
WASHINGTON— Federal regulators warned doctors Tuesday about severe skin reactions seen in patients taking an injectable treatment for alcoholism made by Alkermes Inc. and marketed by Cephalon Inc. The Food and Drug Administration said physicians Source: www.boston.com Michael Phelps' 12,000 Calorie-a-Day Diet Not for Everyone - FOX News Altogether, Phelps consumes 12,000 calories a day while in training. Compared to the 2,500-3,000 calories a day the U.S. Food and Drug Administration recommends for men depending on age and activity level, Phelps diet seems outrageous. But it is, in Source: www.foxnews.com FDA warns of reactions to alcohol dependence drug - Reuters WASHINGTON (Reuters) - Nearly 200 patients given Alkermes Inc's drug Vivitrol for alcohol dependence reported complications from the injection, including abscesses requiring surgical drainage, U.S. health regulators said on Tuesday. Vivitrol, an Source: www.reuters.com Actavis Totowa voluntarily recalls drugs - Newsday LITTLE FALLS. N.J. - Actavis Totowa is voluntarily recalling more than 60 generic drugs from hospitals and pharmacies that were manufactured at its Little Falls plant. The Food and Drug Administration earlier this year found the plant did not meet Source: www.newsday.com Vermont and 46 states say Wyeth at fault in Vermont drug case - WCAX MONTPELIER, Vt. (AP) - Vermont and 46 states are urging the U.S. Supreme Court to uphold a Vermont Supreme court ruling that forced a drug manufacturer to pay $6.8 million to a woman whose arm had to be amputated after she was injected with 1 of its Source: www.wcax.com Levitronix CentriMag Extracorporeal Blood Pumping System: CentriMag Primary Console (with v200 Application Software) Levitronix CentriMag Extracorporeal Blood Pumping System: CentriMag Primary Console (with v200 Application Software)
Physicians warned not to use Blood Pumping System with Valleylab Force FX-C or SSE2L electrosurgery devices because use may result in stoppage of the pump and may cause serious injury or death. Simvastatin Used With Amiodarone Risk of rhabdomyolysis when simvastatin is used with amiodarone, particularly with simvastatin doses greater than 20 mg daily. Federal Agents Seize more than $24 Million in Unapproved New Drugs Representatives of the U.S. Food and Drug Administration and the U.S. Marshals Service today seized $24.2 million worth of unapproved new drugs from KV Pharmaceutical Company of St. Louis, Mo. Agents acted after United States Attorney Catherine L. Hanaway filed a civil forfeiture suit and obtained a warrant to seize the unapproved new drug products being made by KV Pharmaceutical. FDA Announces Improved Policies Regarding Transparency, Public Disclosure for Advisory Committees The Food and Drug Administration today announced several improved policies and procedures strengthening its management of FDA advisory committees. The improvements include stricter limits on financial conflicts of interest for committee members, improved voting procedures, and improvements to the processes for disclosing information pertaining both to advisory committee members and to specific matters considered at advisory committee meetings. FDA Clears Test that Helps Identify Type of Cancer in Tumor Sample The U.S. Food and Drug Administration has cleared for marketing a test that can help health care professionals determine what type of cancer cells are present in a malignant tumor. The Pathwork Tissue of Origin test compares the genetic material of a patient's tumor with genetic information on malignant tumor types stored in a database. August 2008 Patient Safety News Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. C.F. Sauer Foods Issues Allergy Alert on Undeclared Milk in one lot of Gold Medal Spaghetti Sauce Mix (August 4) CF Sauer Foods Inc, of Richmond, VA is recalling all packages of Gold Medal Spaghetti Sauce Mix with the code date as follows: 8119R. People who have an allergy or severe sensitivity to milkrun the risk of serious or life threatening allergic reaction if they consume these products. Erythropoiesis Stimulating Agents (ESAs) - Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp) UPDATE - Dear Healthcare Professional letter added. FDA Advises Against Consumption of American Lobster (Maine Lobster) Tomalley The U.S. Food and Drug Administration today warned consumers to avoid eating tomalley in American Lobster (Maine Lobster), regardless of where the lobster was harvested, because of potential contamination with dangerous levels of the toxins that cause Paralytic Shellfish Poisoning (PSP). Fentanyl Transdermal System CII Patches UPDATE - Voluntary recall because one lot of the product contained patches leaking fentanyl gel. Sage Products Inc. Issues Voluntary Recall of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation (June 27) 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). Federal Authorities Seize Xiadafil VIP Tablets After Company Refuses to Recall Product (July 24) At the request of the U.S. Food and Drug Administration, U.S. Marshals seized nearly $74,000 worth of Xiadafil VIP tablets, Lots 6K029 and 6K209-SEI, distributed by SEI Pharmaceuticals, Inc. of Miami, Fla. Although marketed as a dietary supplement to treat erectile dysfunction (ED) and for sexual enhancement, these lots represent an illegally marketed drug containing an undeclared ingredient. EG Labs Announces Urgent Nationwide Voluntary Recall of ALL LOTS of Viapro 375 mg Capsules, due to a Potentially Harmful Ingredient EG Labs, LLC, announced today that it is conducting a nationwide voluntary recall of all lots of its supplement product sold under the brand name, Viapro, in 375mg capsules. EG Labs, LLC. is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of a sample from one lot of the product revealed that it contained a potentially harmful undeclared ingredient, thio-methisosildenafil. Stronger Warnings Requested for Fluoroquinolones Stronger Warnings Requested for Fluoroquinolones
FDA has notified manufacturers of fluoroquinolones that a boxed warning on the increased risk of tendinitis and tendon rupture is necessary. Drug Shortages: Drugs to be Discontinued; Geref Diagnostic EMD Serono has made a business decision to discontinue this product. FDA 101: Biological Products Basic facts about biologics, products that replicate natural biologic substances such as enzymes, antibodies, or hormones in our bodies. Stay Healthy While Traveling Abroad Getting sick can ruin your trip. FDA shares the guidance it gives to overseas inspectors to help them remain healthy while traveling abroad. Radiology and Children: Extra Care Required Image Gently, a campaign launched this year, aims to raise awareness about opportunities to lower the radiation dose during the medical imaging of children. Recalls and Safety Alerts: Warning Added to Regranex Label A boxed warning alerting healthcare professionals to an increased risk of cancer death has been added to the labeling for Regranex (becaplermin), a topical medication used to treat certain diabetic foot and leg ulcers. Based on a review of an ea... Wrinkle Relief: Injectable Cosmetic Fillers Injectable wrinkle fillers can restore a smoother appearance to your face, but here's what to consider before having this cosmetic procedure done. Are You Storing Food Safely? When, where, and how you store food can help prevent foodborne illnesses. Here are pointers for safely storing food in your refrigerator, freezer, and cupboards. Resolved Drug Shortage: Digoxin oral tablets See website for more information about this resolved shortage. Drug Shortage: Drug to be Discontinued; Revex (Nalmefene HCl Injection) Baxter has discontinued Revex production. Checklists to Help You Stay Healthy - Health and Age.com Checklists to Help You Stay Healthy - Health and Age.com
The US Agency for Healthcare Research and Quality (AHRQ) and the AARP have released two new checklists that are designed to help men over the age of 50 learn how to stay healthy. Select Focus Topic.. Alzheimer's Disease Arthritis and Gout Cancer Source: www.healthandage.com Airborne Coughs Up Millions to Settle Suit - Washington Post Victoria Knight-McDowell created Airborne, which the FTC says has no proof of being a cure for the common cold. (By John Todd -- Associated Press) Over the past decade, millions of consumers, including Oprah, have come to swear by Airborne -- fizzy Source: www.washingtonpost.com Insiders Buy Staar Surgical as Lasik Alternate Shows Potential - Bloomberg Aug. 15 (Bloomberg) -- Staar Surgical Co. insiders and investors are buying stock as they bet the company's $3,081 lens implants to correct nearsightedness will gain on less-costly Lasik treatments, increasing the potential for a takeover. Five Source: www.bloomberg.com St. Jude Medical gets FDA, European CE Mark approval for EonC - Forbes BOSTON (Thomson Financial) - St. Jude Medical Inc. Wednesday said it has received approval from the Food and Drug Administration and European CE Mark for EonC, a non-rechargeable neurostimulator for the treatment of chronic pain. The medical device Source: www.forbes.com Ranbaxy Drugs Win Approval Amid U.S. Probe on Data (Update1) - Bloomberg Aug. 13 (Bloomberg) -- The Food and Drug Administration approved 18 generic drugs made by Ranbaxy Laboratories Ltd. even as the U.S. investigated whether the company fabricated data to get its medicines cleared. The FDA has been aware of the Source: www.bloomberg.com FDA Warns on Alkermes Drug - Street.Com The Food and Drug Administration warned medical professionals on Tuesday of the risk of adverse reactions at the injection site in patients given alcohol dependence drug naltrexone. Regulators said they received 196 reports of injection site Source: www.thestreet.com FDA approves St. Jude treatment for chronic pain - CNN Money NEW YORK (Associated Press) - St. Jude Medical Inc. announced Wednesday that its EonC neurostimulator for chronic pain treatment received U.S. Food and Drug Administration and European CE Mark approvals. The device treats complex neuropathic pain of Source: money.cnn.com August 14, 2008FDA Extends Consumer Warning on Serrano Peppers from Mexico FDA Extends Consumer Warning on Serrano Peppers from Mexico
Laboratory testing by the U.S. Food and Drug Administration has confirmed that both a sample of serrano pepper and a sample of irrigation water collected by agency investigators on a farm in the state of Nuevo Leon, Mexico, contain Salmonella Saintpaul with the same genetic fingerprint as the strain of bacteria that is causing the current outbreak in the United States. FDA Consumer Corner: Nonoxynol 9 Contraceptives: No Protection against HIV and Other STDs The Food and Drug Administration wants to be sure that consumers know about new warnings on over-the-counter vaginal contraceptive products that contain the spermicide ingredient nonoxynol 9 (N9). These products include spermicidal gels, foams, film... FDA warns of reactions to anti-alcohol drug - MSNBC FDA warns of reactions to anti-alcohol drug - MSNBC
WASHINGTON - Nearly 200 patients given Alkermes Inc’s drug Vivitrol for alcohol dependence reported complications from the injection, including abscesses requiring surgical drainage, U.S. health regulators warned on Tuesday. The Food and Drug Source: www.msnbc.msn.com Boston Scientific recalls artery-opening stents - International Herald Tribune WASHINGTON : Medical device maker Boston Scientific Corp. has recalled some of its artery-opening stents due to a defect that can cause part of the devices to break off during surgery. The Food and Drug Administration said Thursday the recall affects Source: www.iht.com Vermont and 46 states say Wyeth at fault in Vermont drug case - WCAX MONTPELIER, Vt. (AP) - Vermont and 46 states are urging the U.S. Supreme Court to uphold a Vermont Supreme court ruling that forced a drug manufacturer to pay $6.8 million to a woman whose arm had to be amputated after she was injected with 1 of its Source: www.wcax.com Michael Phelps' 12,000 Calorie-a-Day Diet Not for Everyone - FOX News Altogether, Phelps consumes 12,000 calories a day while in training. Compared to the 2,500-3,000 calories a day the U.S. Food and Drug Administration recommends for men depending on age and activity level, Phelps diet seems outrageous. But it is, in Source: www.foxnews.com Anti-booze drug has risks - Philadelphia Daily News WASHINGTON - Federal regulators warned doctors yesterday about severe skin reactions seen in patients taking an injectable treatment for alcoholism made by Alkermes Inc. and marketed by Cephalon Inc. The Food and Drug Administration said patients Source: www.philly.com FDA warns of skin reactions with alcoholism drug - Boston Globe WASHINGTON— Federal regulators warned doctors Tuesday about severe skin reactions seen in patients taking an injectable treatment for alcoholism made by Alkermes Inc. and marketed by Cephalon Inc. The Food and Drug Administration said physicians Source: www.boston.com FDA warns of reactions to alcohol dependence drug - Reuters WASHINGTON (Reuters) - Nearly 200 patients given Alkermes Inc's drug Vivitrol for alcohol dependence reported complications from the injection, including abscesses requiring surgical drainage, U.S. health regulators said on Tuesday. Vivitrol, an Source: www.reuters.com Warnings on Raw Jalapeño and Serrano Peppers from Mexico Warnings on Raw Jalapeño and Serrano Peppers from Mexico
Until further notice, FDA is advising consumers to avoid raw serrano peppers from Mexico, in addition to raw jalapeño peppers from Mexico, and any foods that contain them. Prepare for Hurricanes and Floods: Advice From FDA This updated article gives tips on how to keep food, medical products, and pets safe during an emergency. Strengthening the Advisory Committee Process FDA is strengthening the process by which it gets expert, independent advice that affects new treatments and other products available to consumers. Making Sense of Vytorin Concerns This article clarifies the results of a study that was published in the New England Journal of Medicine, and emphasizes the importance of continuing on prescribed cholesterol medications. FDA Law Enforcers Protect Consumers' Health Inside the FDA's Office of Criminial Investigations FDA 101: Dietary Supplements Part of the "FDA 101" series, this article describes how dietary supplements are regulated and offers safety tips for consumers. 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. FDA Warns Consumers About Potential Problems at Two Baltimore Pharmacies The U.S. Food and Drug Administration 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. The FDA is particularly concerned because a number of the drugs are for serious diseases and could have an adverse effect on treatment. Abbott and AstraZeneca Expand Relationship to Include Co-Promotion of - MSN MoneyCentral Abbott and AstraZeneca Expand Relationship to Include Co-Promotion of - MSN MoneyCentral
ABBOTT PARK, Ill. and WILMINGTON, Del. , Aug. 14 /PRNewswire-FirstCall/ -- Abbott ( NYSE: ABT ) and AstraZeneca AZN announced today that they have entered into an agreement for Abbott to promote AstraZeneca's CRESTOR(R) (rosuvastatin calcium), a Source: news.moneycentral.msn.com Official: China food regulator's death accidental - San Diego Union-Tribune BEIJING – The head of China's food safety watchdog has died in an accident, an official said Wednesday, amid a probe into his financial status. A spokeswoman for the agency said Wu Jianping died after falling from a building in an accident on Aug Source: www.signonsandiego.com LegalView Launches Viapro Drug Recall Site Due to Dangerous Ingredient - Transworld News LegalView, the number one resource for everything and anything legal on the Web, recently launched a new information portal informing readers of a drug recall that could cause serious side effects to its patients. Viapro, from EG Labs, was Source: www.transworldnews.com Abbott faces more litigation over AIDS drug - Associated Press SAN FRANCISCO (AP) -- When Abbott Laboratories Inc. hiked up the price of a popular AIDS drug by 400 percent in 2003, executives prepared for the inevitable public relations hit, but assured themselves the backlash would be brief. Nearly five years Source: hosted.ap.org Meridian Bioscience Provides Sales and Earnings Guidance for Fiscal - Forbes Meridian Bioscience, Inc., Cincinnati, Ohio (NASDAQ: VIVO) today provided the financial community with guidance regarding the Company's fiscal 2009 sales and earnings estimates. Based on the Company's business planning and budgeting activities for Source: www.forbes.com ARCA biopharma Appoints William R. Hiatt as Director of Clinical and - MSN MoneyCentral BROOMFIELD, Colo. , Aug. 14 /PRNewswire/ -- ARCA biopharma, Inc., a biopharmaceutical company developing genetically-targeted therapies for heart failure and other cardiovascular diseases, announced today that it has appointed William R. Hiatt , MD Source: news.moneycentral.msn.com Boston Scientific Stent Study Flawed - Wall Street Journal A heart stent manufactured by Boston Scientific Corp. and expecting approval for U.S. sales is backed by flawed research despite the company's claims of success in a clinical trial, according to a Wall Street Journal review of the data. Boston Source: online.wsj.com Roxane Laboratories, Inc. Initiates a Nationwide Voluntary Recall of Two Manufacturing Lots of Sodium Polystyrene Sulfonate Suspension in the US and Puerto Rico (July 14) Roxane Laboratories, Inc. Initiates a Nationwide Voluntary Recall of Two Manufacturing Lots of Sodium Polystyrene Sulfonate Suspension in the US and Puerto Rico (July 14)
Roxane Laboratories, Inc. announced today that it is conducting a nationwide voluntary recall of two manufacturing lots of Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles (NDC 0054-0165-51; Lot 856396A Exp April 2010, and Lot 856693A Exp May 2010). Strengthening the Advisory Committee Process FDA is strengthening the process by which it gets expert, independent advice that affects new treatments and other products available to consumers. Federal Authorities Seize Xiadafil VIP Tablets After Company Refuses to Recall Product (July 24) At the request of the U.S. Food and Drug Administration, U.S. Marshals seized nearly $74,000 worth of Xiadafil VIP tablets, Lots 6K029 and 6K209-SEI, distributed by SEI Pharmaceuticals, Inc. of Miami, Fla. Although marketed as a dietary supplement to treat erectile dysfunction (ED) and for sexual enhancement, these lots represent an illegally marketed drug containing an undeclared ingredient. Vita Food Products Issues Alert Regarding Vita Nova Salmon (July 25) The product that is the subject of this public announcement and recall are packages (deep dark blue in color) of smoked salmon that bear the Vita logo in the upper left corner on the part of the packaging that is immediately visible to the consumer. Each package contains 4-10 bacon-style slices (total 3 oz.) of smoked salmon; the slices are contained in a vacuum pack within a box that is 4" wide by 7.5" in length by 1/2" in thickness. IMPORTANT: The Code Date of 11/16/08 198 is on the left end flap of each package. This announcement and recall only applies to packages that bear that CODE DATE. Publix Issues Recall for No Sugar Added Cherry Pie (July 24) Publix Super Markets is issuing a voluntary recall on three codes of No Sugar Added Cherry Pie with a sell-by-date of July 8 – July 27. UPC numbers for the affected product may be found on the back label below the Nutritional Facts panel: Publix NSA 8inch Cherry Pie, UPC: 41415-65990; Publix NSA 1/2 Cherry Pie, UPC: 03000-00225; and Publix NSA 1/4 Cherry Pie, UPC: 41415-66990. Agricola Zaragoza, Inc. Recalls Jalapeno Peppers Because of Possible Health Risk (July 21) The recall is a result of sampling by FDA, which revealed that these Jalapeno Peppers were contaminated with the same strain of Salmonella Saintpaul responsible for the current Salmonella outbreak. It is unknown at this time which, if any, of the more than 1,200 illnesses reported to date are related to this particular product or to the grower who supplied this product. Distribution of these products has been suspended while FDA, the Texas Department of State Health Services and the company continue their investigation as to the source of the problem. FDA Extends Consumer Warning on Serrano Peppers from Mexico Laboratory testing by the U.S. Food and Drug Administration has confirmed that both a sample of serrano pepper and a sample of irrigation water collected by agency investigators on a farm in the state of Nuevo Leon, Mexico, contain Salmonella Saintpaul with the same genetic fingerprint as the strain of bacteria that is causing the current outbreak in the United States. 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). FDA Advises Against Consumption of American Lobster (Maine Lobster) Tomalley The U.S. Food and Drug Administration today warned consumers to avoid eating tomalley in American Lobster (Maine Lobster), regardless of where the lobster was harvested, because of potential contamination with dangerous levels of the toxins that cause Paralytic Shellfish Poisoning (PSP). 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. Gilead’s AIDS Drug Viread Gets FDA Clearance For Hepatitis B - Eflux Media Gilead’s AIDS Drug Viread Gets FDA Clearance For Hepatitis B - Eflux Media
Gilead Sciences Inc.’ AIDS drug Viread received the Food and Drug Administration’ s approval on Monday as hepatitis B treatment. Viread is an antiretroviral drug, which has been available in Europe as a part of combination therapy for HIV Source: www.efluxmedia.com FDA Issues Warning About Alkermes Inc’s Alcoholism Drug - Vivitrol - Eflux Media On Tuesday, US health regulators released a rather concerning statement which said almost two hundred patients with alcohol dependence, following a treatment with Alkermes Inc's drug called Vivitrol, have experienced serious complications after Source: www.efluxmedia.com FDA warns of reactions to alcohol dependence drug - Reuters WASHINGTON (Reuters) - Nearly 200 patients given Alkermes Inc's drug Vivitrol for alcohol dependence reported complications from the injection, including abscesses requiring surgical drainage, U.S. health regulators warned on Tuesday. The Food and Source: www.reuters.com FDA warns of skin reactions with alcoholism drug - Boston Globe FDA warns of skin reactions with alcoholism drug - Boston Globe
WASHINGTON— Federal regulators warned doctors Tuesday about severe skin reactions seen in patients taking an injectable treatment for alcoholism made by Alkermes Inc. and marketed by Cephalon Inc. The Food and Drug Administration said physicians Source: www.boston.com FDA Issues Warning About Alkermes Inc’s Alcoholism Drug - Vivitrol - Eflux Media On Tuesday, US health regulators released a rather concerning statement which said almost two hundred patients with alcohol dependence, following a treatment with Alkermes Inc's drug called Vivitrol, have experienced serious complications after Source: www.efluxmedia.com Gilead’s AIDS Drug Viread Gets FDA Clearance For Hepatitis B - Eflux Media Gilead Sciences Inc.’ AIDS drug Viread received the Food and Drug Administration’ s approval on Monday as hepatitis B treatment. Viread is an antiretroviral drug, which has been available in Europe as a part of combination therapy for HIV Source: www.efluxmedia.com Pain Therapeutics, King drug gets priority review - Forbes Pain Therapeutics Inc. and King Pharmaceuticals Inc. said Tuesday the Food and Drug Administration granted the drug developers' pain treatment candidate Remoxy priority review. The FDA generally reviews applications designated as "priority" within Source: www.forbes.com FDA warns of reactions to alcohol dependence drug - Reuters WASHINGTON (Reuters) - Nearly 200 patients given Alkermes Inc's drug Vivitrol for alcohol dependence reported complications from the injection, including abscesses requiring surgical drainage, U.S. health regulators warned on Tuesday. The Food and Source: www.reuters.com Questions surround death of food-safety official in China - International Herald Tribune BEIJING : One of China's highest-ranking food safety officials committed suicide earlier this month during a government corruption investigation, according to a report in a respected Chinese business magazine, though his agency disputed the Source: www.iht.com Official: China food regulator's death accidental - San Diego Union-Tribune BEIJING – The head of China's food safety watchdog has died in an accident, an official said Wednesday, amid a probe into his financial status. A spokeswoman for the agency said Wu Jianping died after falling from a building in an accident on Aug Source: www.signonsandiego.com Today in History - Aug. 14 - FOX News One hundred years ago, on Aug. 14, 1908, rioting erupted in Springfield, Ill., as a white mob, enraged that two black criminal suspects (one later convicted of murder, the other exonerated of rape) had been spirited away from the city jail by Source: www.foxnews.com UPDATE 1-FDA warns of reactions to alcohol dependence drug - Reuters WASHINGTON, Aug 12 (Reuters) - Nearly 200 patients given Alkermes Inc's (ALKS.O: Quote , Profile , Research , Stock Buzz ) drug Vivitrol for alcohol dependence reported complications from the injection, including abscesses requiring surgical drainage Source: www.reuters.com August 13, 2008Recalls and Safety Alerts: Cellcept and Myfortic Linked to Birth Defects and Fetal Loss Recalls and Safety Alerts: Cellcept and Myfortic Linked to Birth Defects and Fetal Loss
FDA is advising healthcare professionals about an increased risk of fetal harm when women become pregnant while being treated with the immunosuppressant drugs Cellcept (mycophenolate mofetil) or Myfortic (mycophenolic acid). Myfortic is approved t... Drug Shortages: Drugs to be Discontinued; Geref Diagnostic EMD Serono has made a business decision to discontinue this product. Drug Shortage: Fentanyl transdermal patch Availability information updated. Sage Products Inc. Issues Voluntary Recall of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation (June 27) 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). Home Made Brand Foods Recalls Tuna Salad Because of Possible Health Risk (August 11) Home Made Brand Foods is voluntarily recalling approximately 4890 pounds of Ready-to-Eat Tuna Salad with an expiration date of 8/19/08. This product has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Federal Authorities Seize Xiadafil VIP Tablets After Company Refuses to Recall Product (July 24) At the request of the U.S. Food and Drug Administration, U.S. Marshals seized nearly $74,000 worth of Xiadafil VIP tablets, Lots 6K029 and 6K209-SEI, distributed by SEI Pharmaceuticals, Inc. of Miami, Fla. Although marketed as a dietary supplement to treat erectile dysfunction (ED) and for sexual enhancement, these lots represent an illegally marketed drug containing an undeclared ingredient. FDA Warns Consumers About Potential Problems at Two Baltimore Pharmacies FDA Warns Consumers About Potential Problems at Two Baltimore Pharmacies
The U.S. Food and Drug Administration 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. The FDA is particularly concerned because a number of the drugs are for serious diseases and could have an adverse effect on treatment. Manufacturer for Wegmans Brand Sorbet Issues an Allergen Alert for Undeclared Milk on a Limited Number of Wegmans Brand Sorbets (July 31) The manufacturer of Wegmans Sorbet is recalling a limited number of 16 oz. Wegmans brand Sorbets because they may contain undeclared milk. People who have an allergy to milk run the risk of a serious or possible life-threatening allergic reaction if they consume the affected products. Pet Food Products Seized at PETCO Distribution Center Consumers who bought animal food products from PETCO in 16 states should take certain precautions 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. Publix Issues Recall for No Sugar Added Cherry Pie (July 24) Publix Super Markets is issuing a voluntary recall on three codes of No Sugar Added Cherry Pie with a sell-by-date of July 8 – July 27. UPC numbers for the affected product may be found on the back label below the Nutritional Facts panel: Publix NSA 8inch Cherry Pie, UPC: 41415-65990; Publix NSA 1/2 Cherry Pie, UPC: 03000-00225; and Publix NSA 1/4 Cherry Pie, UPC: 41415-66990. FDA OKs St. Jude chronic pain device - Minneapolis-St Paul Business Journal FDA OKs St. Jude chronic pain device - Minneapolis-St Paul Business Journal
St. Jude Medical Inc. has received regulatory approval to market a device used to treat chronic pain, the company said Wednesday. The neurostimulation device, dubbed EonC, uses electrical pulses to prevent pain signals from reaching the brain. It Source: twincities.bizjournals.com Ranbaxy Drugs Win Approval Amid U.S. Probe on Data (Update1) - Bloomberg Aug. 13 (Bloomberg) -- The Food and Drug Administration approved 18 generic drugs made by Ranbaxy Laboratories Ltd. even as the U.S. investigated whether the company fabricated data to get its medicines cleared. The FDA has been aware of the Source: www.bloomberg.com Gilead’s AIDS Drug Viread Gets FDA Clearance For Hepatitis B - Eflux Media Gilead Sciences Inc.’ AIDS drug Viread received the Food and Drug Administration’ s approval on Monday as hepatitis B treatment. Viread is an antiretroviral drug, which has been available in Europe as a part of combination therapy for HIV Source: www.efluxmedia.com Express Scripts spent $210K lobbying gov't in 2Q - CNBC WASHINGTON - Pharmacy benefit manager Express Scripts Inc. spent $210,000 lobbying in the second quarter on issues affecting pharmacies, prescription drugs and health information technology, according to a recent disclosure form. The St. Louis-based Source: www.cnbc.com FDA Grants Full Approval of PROCLEIX(R) ULTRIO(R) Blood Screening - Forbes SAN DIEGO, Aug. 13 /PRNewswire-FirstCall/ -- Gen-Probe Incorporated (Nasdaq: GPRO) announced today that the US Food and Drug Administration (FDA) has approved its supplemental regulatory application to use the PROCLEIX(R) ULTRIO(R) assay to screen Source: www.forbes.com Schering Drug Derailed by Power of One - Street.Com OKLAHOMA CITY -- Did a single patient's allergic reaction, one that was overcome without any major complications, ultimately cripple plans for Schering-Plough's SGP breakthrough anesthesia drug? During early clinical trials of Sugammadex, a novel Source: www.thestreet.com FDA Approves Combination Blood Pressure Pill - Health and Age.com Last week, the US Food and Drug Administration (FDA) approved a blood pressure pill which combines two common blood pressure medications - valsartan and amlodipine - as first-line treatment for patients who are likely to need multiple drugs to lower Source: www.healthandage.com Roxane Laboratories, Inc. Initiates a Nationwide Voluntary Recall of Two Manufacturing Lots of Sodium Polystyrene Sulfonate Suspension in the US and Puerto Rico (July 14) Roxane Laboratories, Inc. Initiates a Nationwide Voluntary Recall of Two Manufacturing Lots of Sodium Polystyrene Sulfonate Suspension in the US and Puerto Rico (July 14)
Roxane Laboratories, Inc. announced today that it is conducting a nationwide voluntary recall of two manufacturing lots of Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles (NDC 0054-0165-51; Lot 856396A Exp April 2010, and Lot 856693A Exp May 2010). FDA Warns Consumers About Potential Problems at Two Baltimore Pharmacies The U.S. Food and Drug Administration 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. The FDA is particularly concerned because a number of the drugs are for serious diseases and could have an adverse effect on treatment. 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. Radiology and Children: Extra Care Required Image Gently, a campaign launched this year, aims to raise awareness about opportunities to lower the radiation dose during the medical imaging of children. Manufacturer for Wegmans Brand Sorbet Issues an Allergen Alert for Undeclared Milk on a Limited Number of Wegmans Brand Sorbets (July 31) The manufacturer of Wegmans Sorbet is recalling a limited number of 16 oz. Wegmans brand Sorbets because they may contain undeclared milk. People who have an allergy to milk run the risk of a serious or possible life-threatening allergic reaction if they consume the affected products. 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). Vita Food Products Issues Alert Regarding Vita Nova Salmon (July 25) The product that is the subject of this public announcement and recall are packages (deep dark blue in color) of smoked salmon that bear the Vita logo in the upper left corner on the part of the packaging that is immediately visible to the consumer. Each package contains 4-10 bacon-style slices (total 3 oz.) of smoked salmon; the slices are contained in a vacuum pack within a box that is 4" wide by 7.5" in length by 1/2" in thickness. IMPORTANT: The Code Date of 11/16/08 198 is on the left end flap of each package. This announcement and recall only applies to packages that bear that CODE DATE. Stronger Warnings Requested for Fluoroquinolones Stronger Warnings Requested for Fluoroquinolones
FDA has notified manufacturers of fluoroquinolones that a boxed warning on the increased risk of tendinitis and tendon rupture is necessary. Are You Storing Food Safely? When, where, and how you store food can help prevent foodborne illnesses. Here are pointers for safely storing food in your refrigerator, freezer, and cupboards. Cardiome Pharma shares plunge on FDA request - Forbes Cardiome Pharma shares plunge on FDA request - Forbes
Canadian drug developer Cardiome Pharma Inc. said Monday the U.S. Food and Drug Administration wants more information on its abnormal heart rhythm drug, posing a regulatory delay and sinking shares in morning trading. The stock plummeted $3.23, or 27 Source: www.forbes.com FDA Approves Combination Blood Pressure Pill - Health and Age.com Last week, the US Food and Drug Administration (FDA) approved a blood pressure pill which combines two common blood pressure medications - valsartan and amlodipine - as first-line treatment for patients who are likely to need multiple drugs to lower Source: www.healthandage.com FDA approvals clear way for flu vaccine marketing - Centre For Infectious Disease Research and Policy Editor's note: This story was updated Aug 7 to include information about the start of influenza vaccine shipments by Novartis. Aug 6, 2008 (CIDRAP News) – The six companies that make influenza vaccine for the US market have won federal approval for Source: www.cidrap.umn.edu Ranbaxy Drugs Win Approval Amid Probe Whether Data Were False - Bloomberg Aug. 13 (Bloomberg) -- The Food and Drug Administration approved 18 generic drugs made by Ranbaxy Laboratories Ltd. even as the U.S. investigated whether the company fabricated data to get its medicines cleared. The FDA has been aware of the Source: www.bloomberg.com FDA Warns on Alkermes Drug - Street.Com The Food and Drug Administration warned medical professionals on Tuesday of the risk of adverse reactions at the injection site in patients given alcohol dependence drug naltrexone. Regulators said they received 196 reports of injection site Source: www.thestreet.com Ranbaxy Drugs Win Approval Amid Probe Whether Data Were False - Bloomberg Ranbaxy Drugs Win Approval Amid Probe Whether Data Were False - Bloomberg
Aug. 13 (Bloomberg) -- The Food and Drug Administration approved 18 generic drugs made by Ranbaxy Laboratories Ltd. even as the U.S. investigated whether the company fabricated data to get its medicines cleared. The FDA has been aware of the Source: www.bloomberg.com Food Trade struggles with open market theories - Thepacker.com (Aug. 4, COLUMN) Food and produce trade have long been in the forefront of globalization. Yet trade in food differs markedly from trade in oil, gold, iron ore and other fungible commodities. Foods, particularly produce, can be differentiated Source: thepacker.com FDA warns of reactions to anti-alcohol drug - MSNBC WASHINGTON - Nearly 200 patients given Alkermes Inc’s drug Vivitrol for alcohol dependence reported complications from the injection, including abscesses requiring surgical drainage, U.S. health regulators warned on Tuesday. The Food and Drug Source: www.msnbc.msn.com China food safety official kills himself amid probe - Straits Times BEIJING - A SENIOR Chinese official in charge of food safety committed suicide after being questioned about suspected corruption, media reported on Wednesday. China's food and drug safety records have come under domestic and international scrutiny Source: www.straitstimes.com Court reinstates Gilead securities-fraud suit - San Francisco Gate del.icio.us On the same day that the FDA approved Gilead Sciences Inc.'s anti-HIV drug Viread for use in fighting hepatitis B, a federal appeals court on Monday reinstated a securities-fraud suit filed by investors who claim the biotech company Source: www.sfgate.com FDA: Heart drug combo may harm muscles - MSNBC WASHINGTON - U.S. health officials warned the public on Friday about the risk of a rare type of muscle injury seen when the cholesterol drug simvastatin is combined with the anti-arrhythmia medicine amiodarone. The Food and Drug Administration said Source: www.msnbc.msn.com FDA issues skin warning about alcoholism therapy - Boston Globe Federal regulators warned doctors about severe skin reactions seen in patients taking an injectable treatment for alcoholism made by Cambridge-based Alkermes Inc. and marketed by Cephalon Inc. The Food and Drug Administration said physicians and Source: www.boston.com August 12, 2008Court reinstates Gilead securities-fraud suit - San Francisco Gate Court reinstates Gilead securities-fraud suit - San Francisco Gate
del.icio.us On the same day that the FDA approved Gilead Sciences Inc.'s anti-HIV drug Viread for use in fighting hepatitis B, a federal appeals court on Monday reinstated a securities-fraud suit filed by investors who claim the biotech company Source: www.sfgate.com New subdecree to target counterfeit, harmful cosmetics - Phnom Penh Post In 2001 the European Union banned whitening creams containing the popular chemical hydroquinone after it linked it to dermatological side effects. Thailand’s food and drug administration currently has a list of 70 illegal whitening creams. T HE Source: www.phnompenhpost.com Fresenius to invest € 30 mn in Dabur - Daily News and Analysis NEW DELHI: Multinational drug firm Fresenius Kabi, which acquired Dabur Pharma, is looking to expand the latter's oncology business globally with plans of investing up to € 30 million (about Rs 190 crore) in the next 2-3 years. The investments will Source: www.dnaindia.com AbSorber: FDA Approves Registration of AbSorber ’ s Transplantation - Businesswire.com STOCKHOLM, Sweden--( BUSINESS WIRE )--The Swedish biotech company AbSorber has been given clearance by the U.S. Food and Drug Administration (FDA) to market and sell its XM-ONE ® transplantation test in the U.S. Initially, sales of XM-ONE ® in the Source: www.businesswire.com Cardiome Pharma shares plunge on FDA request - Forbes Cardiome Pharma shares plunge on FDA request - Forbes
Canadian drug developer Cardiome Pharma Inc. said Monday the U.S. Food and Drug Administration wants more information on its abnormal heart rhythm drug, posing a regulatory delay and sinking shares. The stock plummeted $3.23, or 27 percent, to $8.72 Source: www.forbes.com Pain Therapeutics, King drug gets priority review - CNN Money NEW YORK (Associated Press) - Pain Therapeutics Inc. and King Pharmaceuticals Inc. said Tuesday the Food and Drug Administration granted the drug developers' pain treatment candidate Remoxy priority review. The FDA generally reviews applications Source: money.cnn.com FDA: Some cholesterol and heart drugs don't mix - Associated Press WASHINGTON (AP) -- Patients taking some common medications for high cholesterol and irregular heart beats can suffer severe muscle damage because of a problem in the way the drugs interact, the government warned on Friday. The Food and Drug Source: hosted.ap.org FDA Approves Viread for Chronic Hepatitis B in Adults - eMaxHealth.com Gilead says Viread is an important life-threatening liver disease treatment medication that will reach to millions of patients in the United States after the FDA approval. Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the U.S. Food and Source: www.emaxhealth.com AbSorber: FDA Approves Registration of AbSorber's Transplantation Test - PR Inside AbSorber: FDA Approves Registration of AbSorber's Transplantation Test - PR Inside
AbSorber's transplantation test provides enhanced diagnostic value compared to existing tests and facilitates matching the right organ with the right patient, thereby increasing the probability of a successful transplantation. "Approval from the FDA Source: www.pr-inside.com Pain Therapeutics, King drug gets priority review - CNN Money NEW YORK (Associated Press) - Pain Therapeutics Inc. and King Pharmaceuticals Inc. said Tuesday the Food and Drug Administration granted the drug developers' pain treatment candidate Remoxy priority review. The FDA generally reviews applications Source: money.cnn.com India's Aurobindo Pharma gets U.S. FDA approval for Cefazolin - CNBC MUMBAI (Thomson Financial) - India-based Aurobindo Pharma Ltd. said it received approval from the United States Food and Drug Administration (FDA) for Cefazolin, used to treat bacterial infections of the skin. Aurobindo has 74 abbreviated new drug Source: www.cnbc.com Cardiome Pharma shares plunge on FDA request - Forbes Canadian drug developer Cardiome Pharma Inc. said Monday the U.S. Food and Drug Administration wants more information on its abnormal heart rhythm drug, posing a regulatory delay and sinking shares. The stock plummeted $3.23, or 27 percent, to $8.72 Source: www.forbes.com FDA: Heart drug combo may harm muscles - MSNBC WASHINGTON - U.S. health officials warned the public on Friday about the risk of a rare type of muscle injury seen when the cholesterol drug simvastatin is combined with the anti-arrhythmia medicine amiodarone. The Food and Drug Administration said Source: www.msnbc.msn.com Geron and Exeter Life Sciences Merge Start Licensing and ViaGen to - Forbes Geron Corporation (Nasdaq:GERN) and Exeter Life Sciences, Inc. announced today the merger of Start Licensing, Inc. ("Start"), a joint venture between Geron and Exeter Life Sciences, and ViaGen, Inc., a subsidiary of Exeter Life Sciences. Start Source: www.forbes.com FDA approves new drug to treat hepatitis B patients - Overthelimit.info Boston (OTL) - The U.S. Food and Drug Administration (FDA) has approved a Gilead drug named Viread to treat hepatitis B patients. The Gilead drug is also known generically as tenofovir, and was released on the market in the U.S. in 2001 to help Source: www.overthelimit.info FDA approves Gilead AIDS drug for hepatitis B - CNN Money NEW YORK (Associated Press) - Gilead Sciences Inc. is set to expand its reach further beyond AIDS drugs after federal regulators approved the biotech drug maker's signature anti-HIV therapy as a hepatitis B treatment. Gilead announced Monday that the Source: money.cnn.com Cardiome And Astellas Announce Receipt Of FDA Approvable Letter For - Forbes VANCOUVER and DEERFIELD, IL, Aug. 11 /PRNewswire-FirstCall/ - Cardiome Pharma Corp. (NASDAQ: CRME/TSX: COM) and its co-development partner Astellas Pharma US, Inc. ("Astellas") today announced that they have received an action letter dated August 8 Source: www.forbes.com Doctors warn of skin problems from black henna - San Diego Union-Tribune Freshly applied henna adorns the hands of Savani Bhutada, 2, the daughter of La Jolla tattoo artist Snehal Bhutada, who said she never uses black henna. Tattoo lovers, beware. Doctors nationwide are blaming a rash of skin problems – including Source: www.signonsandiego.com Drug Shortage: Fentanyl transdermal patch Drug Shortage: Fentanyl transdermal patch
Availability information updated. Recalls and Safety Alerts: Possible Association between TNF Blockers and Cancer FDA has informed healthcare professionals that it is investigating a possible association between drugs that block tumor necrosis factor (TNF) and the development of lymphoma and other cancers in children and young adults. This is part of FDA's ... Preventing Medical Errors: Potential Problems with Insulin Pens in Hospitals In a recent article, the Institute for Safe Medication Practices (ISMP) highlighted several potential safety problems when hospitals switch from multiple dose vials of insulin to insulin pens. ISMP points out that there are certain safety advant... Recalls and Safety Alerts: Warning Added to Regranex Label A boxed warning alerting healthcare professionals to an increased risk of cancer death has been added to the labeling for Regranex (becaplermin), a topical medication used to treat certain diabetic foot and leg ulcers. Based on a review of an ea... Erythropoiesis Stimulating Agents (ESAs) - Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp) FDA clarifies approved conditions for use of ESAs in patients with cancer and revises dosing directions for the products. FDA approves Gilead AIDS drug for hepatitis B - Forbes FDA approves Gilead AIDS drug for hepatitis B - Forbes
Gilead Sciences Inc. prepared to expand its reach further beyond AIDS drugs Monday after federal regulators approved the biotech drug maker's signature anti-HIV therapy as a hepatitis B treatment. Gilead announced that the Food and Drug Source: www.forbes.com Heparin taint tied to deaths - Chicago Tribune The U.S. Food and Drug Administration, for the first time, has conclusively linked deaths of patients infused with the blood thinner heparin to a foreign substance found in specific lots of the drug made by Deerfield-based Baxter International Inc Source: www.chicagotribune.com India's Cipla gets FDA nod for ramipril capsules - Reuters MUMBAI, Aug 12 (Reuters) - Indian drugmaker Cipla Ltd (CIPL.BO: Quote , Profile , Research , Stock Buzz ) has received approval from the U.S. Food and Drug Administration to market ramipril capsules, the regulator's website showed. The drug, a Source: www.reuters.com Cardiome And Astellas Announce Receipt Of FDA Approvable Letter For - Forbes VANCOUVER and DEERFIELD, IL, Aug. 11 /PRNewswire-FirstCall/ - Cardiome Pharma Corp. (NASDAQ: CRME/TSX: COM) and its co-development partner Astellas Pharma US, Inc. ("Astellas") today announced that they have received an action letter dated August 8 Source: www.forbes.com Dr Reddy's gets FDA nod for osteoporosis drug - Reuters India MUMBAI (Reuters) - Indian drugmaker Dr. Reddy's Laboratories Ltd has received approval from the U.S. Federal Drug Administration to make and market alendronate sodium tablets, the regulator's website showed. The drug, a generic version of Merck's Source: in.reuters.com India's Aurobindo Pharma gets U.S. FDA approval for Cefazolin - CNBC MUMBAI (Thomson Financial) - India-based Aurobindo Pharma Ltd. said it received approval from the United States Food and Drug Administration (FDA) for Cefazolin, used to treat bacterial infections of the skin. Aurobindo has 74 abbreviated new drug Source: www.cnbc.com Movers: Waste Management, ITW, Calpine - BusinessWeek A.C. Moore posts a 21 cents second-quarter loss per share vs. a 3-cent loss on 4.8% lower same-store sales, 1.6% higher total sales. Cardiome and partner Astellas Pharma US, receive action letter from FDA for Kynapid Injection (vernakalant Source: www.businessweek.com Oxygen Biotherapeutics Develops Gel Version of Oxycyte(R) for Treating - PR Inside - Oxygen Biotherapeutics, Inc. (OTCBB:OXBO) today announced that the company has developed a gel-like form of Oxycyte(R) that it intends to investigate as a topical application for open wounds, abrasions and burns. Oxycyte is the Company's Source: www.pr-inside.com Cardiome Pharma shares plunge on FDA request - Forbes Canadian drug developer Cardiome Pharma Inc. said Monday the U.S. Food and Drug Administration wants more information on its abnormal heart rhythm drug, posing a regulatory delay and sinking shares. The stock plummeted $3.23, or 27 percent, to $8.72 Source: www.forbes.com August 11, 2008FDA 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. Vita Food Products Issues Alert Regarding Vita Nova Salmon (July 25) The product that is the subject of this public announcement and recall are packages (deep dark blue in color) of smoked salmon that bear the Vita logo in the upper left corner on the part of the packaging that is immediately visible to the consumer. Each package contains 4-10 bacon-style slices (total 3 oz.) of smoked salmon; the slices are contained in a vacuum pack within a box that is 4" wide by 7.5" in length by 1/2" in thickness. IMPORTANT: The Code Date of 11/16/08 198 is on the left end flap of each package. This announcement and recall only applies to packages that bear that CODE DATE. Stronger Warnings Requested for Fluoroquinolones FDA has notified manufacturers of fluoroquinolones that a boxed warning on the increased risk of tendinitis and tendon rupture is necessary. Publix Issues Recall for No Sugar Added Cherry Pie (July 24) Publix Super Markets is issuing a voluntary recall on three codes of No Sugar Added Cherry Pie with a sell-by-date of July 8 – July 27. UPC numbers for the affected product may be found on the back label below the Nutritional Facts panel: Publix NSA 8inch Cherry Pie, UPC: 41415-65990; Publix NSA 1/2 Cherry Pie, UPC: 03000-00225; and Publix NSA 1/4 Cherry Pie, UPC: 41415-66990. Agricola Zaragoza, Inc. Recalls Jalapeno Peppers Because of Possible Health Risk (July 21) The recall is a result of sampling by FDA, which revealed that these Jalapeno Peppers were contaminated with the same strain of Salmonella Saintpaul responsible for the current Salmonella outbreak. It is unknown at this time which, if any, of the more than 1,200 illnesses reported to date are related to this particular product or to the grower who supplied this product. Distribution of these products has been suspended while FDA, the Texas Department of State Health Services and the company continue their investigation as to the source of the problem. Domega International Co., Ltd. Issues an Alert on Undeclared Sulfites in Korica Brand Mut Gung Sweetened Ginger (July 16) The recalled Korica Brand Mut Gung Sweetened Ginger is sold in uncoded 7 oz plastic tubs and is a product of Vietnam. The product was sold nationwide. Pet Food Products Seized at PETCO Distribution Center Consumers who bought animal food products from PETCO in 16 states should take certain precautions Calif. lawmakers weigh chemical ban in baby items - Miami Herald Calif. lawmakers weigh chemical ban in baby items - Miami Herald
SACRAMENTO, Calif. Responding to growing consumer anxiety, California lawmakers are considering enacting what could be the first statewide restrictions on a chemical found in plastic baby bottles and infant formula cans. The bill would require that Source: www.miamiherald.com Roxane Laboratories, Inc. Initiates a Nationwide Voluntary Recall of Two Manufacturing Lots of Sodium Polystyrene Sulfonate Suspension in the US and Puerto Rico (July 14) Roxane Laboratories, Inc. Initiates a Nationwide Voluntary Recall of Two Manufacturing Lots of Sodium Polystyrene Sulfonate Suspension in the US and Puerto Rico (July 14)
Roxane Laboratories, Inc. announced today that it is conducting a nationwide voluntary recall of two manufacturing lots of Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles (NDC 0054-0165-51; Lot 856396A Exp April 2010, and Lot 856693A Exp May 2010). Agricola Zaragoza, Inc. Recalls Jalapeno Peppers Because of Possible Health Risk (July 21) The recall is a result of sampling by FDA, which revealed that these Jalapeno Peppers were contaminated with the same strain of Salmonella Saintpaul responsible for the current Salmonella outbreak. It is unknown at this time which, if any, of the more than 1,200 illnesses reported to date are related to this particular product or to the grower who supplied this product. Distribution of these products has been suspended while FDA, the Texas Department of State Health Services and the company continue their investigation as to the source of the problem. Manufacturer for Wegmans Brand Sorbet Issues an Allergen Alert for Undeclared Milk on a Limited Number of Wegmans Brand Sorbets (July 31) The manufacturer of Wegmans Sorbet is recalling a limited number of 16 oz. Wegmans brand Sorbets because they may contain undeclared milk. People who have an allergy to milk run the risk of a serious or possible life-threatening allergic reaction if they consume the affected products. Federal Agents Seize more than $24 Million in Unapproved New Drugs Representatives of the U.S. Food and Drug Administration and the U.S. Marshals Service today seized $24.2 million worth of unapproved new drugs from KV Pharmaceutical Company of St. Louis, Mo. Agents acted after United States Attorney Catherine L. Hanaway filed a civil forfeiture suit and obtained a warrant to seize the unapproved new drug products being made by KV Pharmaceutical. Simvastatin Used With Amiodarone Risk of rhabdomyolysis when simvastatin is used with amiodarone, particularly with simvastatin doses greater than 20 mg daily. Erythropoiesis Stimulating Agents (ESAs) - Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp) UPDATE - Dear Healthcare Professional letter added. Salmolux Inc. Recalls Wild Alaskan Smoked Salmon Nova Lox Lot # 01418 Because of Possible Health Risk (July 9) Salmolux Inc. of Federal Way, WA, is recalling lot # 01418 of its Wild Alaskan Smoked Salmon Nova Lox sold in 3 ounce packages due to the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. FDA Advises Against Consumption of American Lobster (Maine Lobster) Tomalley The U.S. Food and Drug Administration today warned consumers to avoid eating tomalley in American Lobster (Maine Lobster), regardless of where the lobster was harvested, because of potential contamination with dangerous levels of the toxins that cause Paralytic Shellfish Poisoning (PSP). FDA Warns Consumers About Potential Problems at Two Baltimore Pharmacies The U.S. Food and Drug Administration 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. The FDA is particularly concerned because a number of the drugs are for serious diseases and could have an adverse effect on treatment. FDA Approves First Generic Divalproex Sodium to Treat Seizures, Migraine Headaches and Bipolar Disorder The U.S. Food and Drug Administration today approved the first generic version of Depakote delayed-release tablets (divalproex sodium). Depakote is approved by the FDA for the treatment of seizures, bipolar disorder and migraine headaches. Calif. Weighs Chemical Ban In Baby Items - CBS News Calif. Weighs Chemical Ban In Baby Items - CBS News
(AP) Responding to growing consumer anxiety, California lawmakers are considering enacting what could be the first statewide restrictions on a chemical found in plastic baby bottles and infant formula cans. The bill would require that all products or Source: www.cbsnews.com Researchers Find Two Popular Fertility Treatments No Better Than - All Headline News London, England (AHN) - Two common fertility treatments involving an ovary-stimulating drug and artificial insemination to improve the chances of conceiving a child yields the same results as no treatment at all, according to a study published Friday Source: www.allheadlinenews.com UPDATE 1-Cardiome stock stung by FDA information request - Reuters TORONTO, Aug 11 (Reuters) - Shares of Cardiome Pharma Corp (COM.TO: Quote , Profile , Research , Stock Buzz ) fell more than 25 percent on Monday after the company said U.S. regulators required more information on its Kynapid treatment for atrial Source: www.reuters.com Firms vie for anthrax pacts - Baltimore Sun Drug companies based in Annapolis and Rockville are battling for potentially lucrative federal contracts to supply at least 25 million doses of new, improved anthrax vaccine to protect Americans against another bioterror attack like the one in 2001 Source: www.baltimoresun.com Cardiome shares nosedive - Globe and Mail Cardiome Pharma saw its shares plummet 30 per cent Monday as one of its key drugs faced further scrutiny from the U.S. Food and Drug Administration. The company's shares were down $3.91 to $9 on the Toronto Stock Exchange. The shares closed Friday at Source: www.theglobeandmail.com Patients taking Zocor or Vytorin and a heart rhythm drug can suffer - Fort Lauderdale Sun-Sentinel WASHINGTON (AP) _ Patients taking some common medications for high cholesterol and irregular heart beats can suffer severe muscle damage because of a problem in the way the drugs interact, the government warned on Friday. The Food and Drug Source: www.sun-sentinel.com Dirty Restaurants: Sounding an Alarm - Time The public-advocacy group that helped maneuver the trans-fats ban in New York City restaurants and pushed national chains to divulge fat and calorie content on their menus is agitating for more change. The Washington-based Center for Science in the Source: www.time.com Will Roche Go "Crazy" For Genentech? - CNBC [ DNA Loading ( ) ] it doesn't currently own. The $44 billion question, of course, is how much more. Shares of DNA keep hitting new highs as investors bet that Roche will revise. We've yet to hear a formal response from the three Source: www.cnbc.com India's Aurobindo Pharma gets U.S. FDA approval for Cefazolin - Forbes India's Aurobindo Pharma gets U.S. FDA approval for Cefazolin - Forbes
MUMBAI (Thomson Financial) - India-based Aurobindo Pharma Ltd. said it received approval from the United States Food and Drug Administration (FDA) for Cefazolin, used to treat bacterial infections of the skin. Aurobindo has 74 abbreviated new drug Source: www.forbes.com India Dr Reddy's gets FDA nod for osteoporosis drug - Reuters India MUMBAI, Aug 11 (Reuters) - Indian drugmaker Dr. Reddy's Laboratories Ltd (REDY.BO: Quote , Profile , Research ) (RDY.N: Quote , Profile , Research ) has received approval from the U.S. Federal Drug Administration to make and market alendronate sodium Source: in.reuters.com FDA warns of heart-drug interactions - TriVallyCentral WASHINGTON (AP) — Patients taking some common medications for high cholesterol and irregular heart beats can suffer severe muscle damage because of a problem in the way the drugs interact, the government warned on Friday. The Food and Drug Source: www.zwire.com Indian shares end stronger; gains led by real estate, banks - CNBC MUMBAI (Thomson Financial) - Indian shares closed higher on sustained buying in real estate, financials, power, auto and fast moving consumer goods. The day's trading fanned out in a range-bound manner at higher levels, with a build-up in buying Source: www.cnbc.com FDA Approves 2008-2009 Flu Vaccines FDA Approves 2008-2009 Flu Vaccines
The U.S. Food and Drug Administration (FDA) today announced that it has approved this year's seasonal influenza vaccines that include new strains of the virus likely to cause flu in the United States during the 2008-2009 season. The six vaccines and their manufacturers are: CSL Limited, Afluria; GlaxoSmithKline Biologicals, Fluarix; ID Biomedical Corporation of Quebec, FluLaval; MedImmune Vaccines Inc., FluMist; Novartis Vaccines and Diagnostics Limited, Fluvirin; and Sanofi Pasteur Inc., Fluzone. Strengthening the Advisory Committee Process FDA is strengthening the process by which it gets expert, independent advice that affects new treatments and other products available to consumers. Warnings on Raw Jalapeño and Serrano Peppers from Mexico Until further notice, FDA is advising consumers to avoid raw serrano peppers from Mexico, in addition to raw jalapeño peppers from Mexico, and any foods that contain them. FDA Announces Improved Policies Regarding Transparency, Public Disclosure for Advisory Committees The Food and Drug Administration today announced several improved policies and procedures strengthening its management of FDA advisory committees. The improvements include stricter limits on financial conflicts of interest for committee members, improved voting procedures, and improvements to the processes for disclosing information pertaining both to advisory committee members and to specific matters considered at advisory committee meetings. How to Dispose of Unused Medicines Is your medicine cabinet filled with expired or unused drugs? Here's how to dispose of them. Living with Fibromyalgia, Drugs Approved to Manage Pain A second drug has been approved to treat fibromyalgia, a painful chronic condition that affects the muscles and joints. Manufacturer for Wegmans Brand Sorbet Issues an Allergen Alert for Undeclared Milk on a Limited Number of Wegmans Brand Sorbets (July 31) Manufacturer for Wegmans Brand Sorbet Issues an Allergen Alert for Undeclared Milk on a Limited Number of Wegmans Brand Sorbets (July 31)
The manufacturer of Wegmans Sorbet is recalling a limited number of 16 oz. Wegmans brand Sorbets because they may contain undeclared milk. People who have an allergy to milk run the risk of a serious or possible life-threatening allergic reaction if they consume the affected products. EG Labs Announces Urgent Nationwide Voluntary Recall of ALL LOTS of Viapro 375 mg Capsules, due to a Potentially Harmful Ingredient EG Labs, LLC, announced today that it is conducting a nationwide voluntary recall of all lots of its supplement product sold under the brand name, Viapro, in 375mg capsules. EG Labs, LLC. is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of a sample from one lot of the product revealed that it contained a potentially harmful undeclared ingredient, thio-methisosildenafil. 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. How to Dispose of Unused Medicines Is your medicine cabinet filled with expired or unused drugs? Here's how to dispose of them. Prepare for Hurricanes and Floods: Advice From FDA This updated article gives tips on how to keep food, medical products, and pets safe during an emergency. Stronger Warnings Requested for Fluoroquinolones FDA has notified manufacturers of fluoroquinolones that a boxed warning on the increased risk of tendinitis and tendon rupture is necessary. Lucky Green Trading, Inc. Recalls Thai Basil Because of Possible Health Risk (July 9) LUCKY GREEN TRADING, INC. of Garden Grove, CA is recalling Thai Basil , because it has the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. August 10, 2008Lucky Green Trading, Inc. Recalls Thai Basil Because of Possible Health Risk (July 9) Lucky Green Trading, Inc. Recalls Thai Basil Because of Possible Health Risk (July 9)
LUCKY GREEN TRADING, INC. of Garden Grove, CA is recalling Thai Basil , because it has the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Levitronix CentriMag Extracorporeal Blood Pumping System: CentriMag Primary Console (with v200 Application Software) Physicians warned not to use Blood Pumping System with Valleylab Force FX-C or SSE2L electrosurgery devices because use may result in stoppage of the pump and may cause serious injury or death. Manufacturer for Wegmans Brand Sorbet Issues an Allergen Alert for Undeclared Milk on a Limited Number of Wegmans Brand Sorbets (July 31) The manufacturer of Wegmans Sorbet is recalling a limited number of 16 oz. Wegmans brand Sorbets because they may contain undeclared milk. People who have an allergy to milk run the risk of a serious or possible life-threatening allergic reaction if they consume the affected products. 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. Recalls and Safety Alerts: Possible Association between TNF Blockers and Cancer FDA has informed healthcare professionals that it is investigating a possible association between drugs that block tumor necrosis factor (TNF) and the development of lymphoma and other cancers in children and young adults. This is part of FDA's ... FDA Extends Consumer Warning on Serrano Peppers from Mexico Laboratory testing by the U.S. Food and Drug Administration has confirmed that both a sample of serrano pepper and a sample of irrigation water collected by agency investigators on a farm in the state of Nuevo Leon, Mexico, contain Salmonella Saintpaul with the same genetic fingerprint as the strain of bacteria that is causing the current outbreak in the United States. Agricola Zaragoza, Inc. Recalls Jalapeno Peppers Because of Possible Health Risk (July 21) The recall is a result of sampling by FDA, which revealed that these Jalapeno Peppers were contaminated with the same strain of Salmonella Saintpaul responsible for the current Salmonella outbreak. It is unknown at this time which, if any, of the more than 1,200 illnesses reported to date are related to this particular product or to the grower who supplied this product. Distribution of these products has been suspended while FDA, the Texas Department of State Health Services and the company continue their investigation as to the source of the problem. FDA Clears Test that Helps Identify Type of Cancer in Tumor Sample The U.S. Food and Drug Administration has cleared for marketing a test that can help health care professionals determine what type of cancer cells are present in a malignant tumor. The Pathwork Tissue of Origin test compares the genetic material of a patient's tumor with genetic information on malignant tumor types stored in a database. FDA Warns Consumers About Potential Problems at Two Baltimore Pharmacies The U.S. Food and Drug Administration 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. The FDA is particularly concerned because a number of the drugs are for serious diseases and could have an adverse effect on treatment. Stop and Shop Alerts Customers to Voluntary Recall of Stop and Shop Brand Garlic Bread and Garlic Spread (June 27) The Stop and Shop Supermarket Company has announced a voluntary recall of Stop and Shop brand garlic bread and garlic spread products sold in its Bakeshop as the items contain milk products which are not declared on the labels. Stop and Shop removed from its shelves all 16 ounce and 9 ounce packages of Stop and Shop brand garlic bread and all 16 ounce packages of Stop and Shop brand garlic spread products. FDA gives priority review to Sanofi's Multaq - Boston Globe FDA gives priority review to Sanofi's Multaq - Boston Globe
PARIS— U.S. regulators have given priority review status to Sanofi-Aventis' Multaq treatment for irregular heartbeat, a ruling that could help speed the drug's launch, the French pharmaceutical company said Friday. Drugs given the Food and Drug Source: www.boston.com Johnson & Johnson drug review delayed by 3 months - Boston Globe NEW BRUNSWICK, N.J.— Johnson & Johnson's Centocor unit said Friday the Food and Drug Administration will take an additional three months to review an application for the experimental psoriasis drug ustekinumab. The company said the review could now Source: www.boston.com Patients taking Zocor or Vytorin and a heart rhythm drug can suffer - Newsday WASHINGTON (AP) _ Patients taking some common medications for high cholesterol and irregular heart beats can suffer severe muscle damage because of a problem in the way the drugs interact, the government warned on Friday. The Food and Drug Source: www.newsday.com Food Safety and Spiders: Food and Drug Administration and Bugs in Food - National Ledger How safe is your food? With the tomatoes scare that hit the industry hard that would eventually turn out to be a jalapeño problem that was causing people to get sick from salmonella many people turn to the Food and Drug Administration (FDA) and the Source: www.nationalledger.com UPDATE 2-Sanofi boosted by priority review for Multaq drug - Reuters LONDON, Aug 8 (Reuters) - Sanofi-Aventis's (SASY.PA: Quote , Profile , Research , Stock Buzz ) experimental heart drug Multaq, which some analysts believe could be worth more than $2 billion in sales a year, is to get a priority review from the U.S Source: www.reuters.com FDA: Some cholesterol and heart drugs don't mix - Forbes Patients taking some common medications for high cholesterol and irregular heart beats can suffer severe muscle damage because of a problem in the way the drugs interact, the government warned on Friday. The Food and Drug Administration said doctors Source: www.forbes.com Food industry bitten by its lobbying success - MSNBC Food industry bitten by its lobbying success - MSNBC
WASHINGTON - One of the worst outbreaks of foodborne illness in the U.S. is teaching the food industry the truth of the adage, "Be careful what you wish for because you might get it." The industry pressured the Bush administration years ago to limit Source: www.msnbc.msn.com FDA gives priority review to Sanofi's Multaq - Boston Globe PARIS— U.S. regulators have given priority review status to Sanofi-Aventis' Multaq treatment for irregular heartbeat, a ruling that could help speed the drug's launch, the French pharmaceutical company said Friday. Drugs given the Food and Drug Source: www.boston.com FDA: Two local pharmacies sold expired medications - Baltimore Sun The Food and Drug Administration says two Baltimore pharmacies sold prescription medications that were expired or suspected to be fake. The medications were sold by the Medicine Shoppe pharmacies at 8035A Liberty Road and 5900 Reisterstown Road. The Source: www.baltimoresun.com FDA: Heart drug combo may harm muscles - MSNBC WASHINGTON - U.S. health officials warned the public on Friday about the risk of a rare type of muscle injury seen when the cholesterol drug simvastatin is combined with the anti-arrhythmia medicine amiodarone. The Food and Drug Administration said Source: www.msnbc.msn.com FDA Extends Review Timeline for Ustekinumab Biologic License - Forbes HORSHAM, Pa., Aug. 8 /PRNewswire/ -- Centocor, Inc., today announced that the U.S. Food and Drug Administration (FDA) has extended the review timeline for the Biologic License Application for ustekinumab, a subcutaneous biologic therapy, by three Source: www.forbes.com U.S. FDA Licenses ADMET Predictor(TM) from Simulations Plus - Forbes Simulations Plus, Inc. (NASDAQ: SLP), a leading provider of software for pharmaceutical discovery and development, today announced that it has received a purchase order from the U.S. Food and Drug Administration (FDA) to license the Company's ADMET Source: www.forbes.com FDA: Some Cholesterol And Heart Drugs Don't Mix - CBS News (AP) Patients taking some common medications for high cholesterol and irregular heart beats can suffer severe muscle damage because of a problem in the way the drugs interact, the government warned on Friday. The Food and Drug Administration said Source: www.cbsnews.com U.S. FDA Licenses ADMET Predictor(TM) from Simulations Plus - Forbes U.S. FDA Licenses ADMET Predictor(TM) from Simulations Plus - Forbes
Simulations Plus, Inc. (NASDAQ: SLP), a leading provider of software for pharmaceutical discovery and development, today announced that it has received a purchase order from the U.S. Food and Drug Administration (FDA) to license the Company's ADMET Source: www.forbes.com FDA: Two local pharmacies sold expired medications - Baltimore Sun The Food and Drug Administration says two Baltimore pharmacies sold prescription medications that were expired or suspected to be fake. The medications were sold by the Medicine Shoppe pharmacies at 8035A Liberty Road and 5900 Reisterstown Road. The Source: www.baltimoresun.com FDA gives priority review to Sanofi's Multaq - Boston Globe PARIS— U.S. regulators have given priority review status to Sanofi-Aventis' Multaq treatment for irregular heartbeat, a ruling that could help speed the drug's launch, the French pharmaceutical company said Friday. Drugs given the Food and Drug Source: www.boston.com FDA: Some cholesterol and heart drugs don't mix - NWITimes.com WASHINGTON - Patients taking some common medications for high cholesterol and irregular heart beats can suffer severe muscle damage because of a problem in the way the drugs interact, the government warned on Friday. The Food and Drug Administration Source: nwitimes.com Loophole in tobacco regulation bill would allow some new product sales - Newsday WASHINGTON (AP) _ A loophole in a sweeping tobacco regulation bill would give the industry a 21-month window to introduce some new products without first getting federal approval. The House last month overwhelmingly passed the legislation, which for Source: www.newsday.com FDA warns of muscle harm when heart drugs combined - Reuters WASHINGTON (Reuters) - U.S. health officials warned the public on Friday about the risk of a rare type of muscle injury seen when the cholesterol drug simvastatin is combined with the anti-arrhythmia medicine amiodarone. The Food and Drug Source: www.reuters.com Stewart subpoena not ruled out - Baltimore Sun WASHINGTON - Lawmakers leading an investigation of Martha Stewart's sale of ImClone Systems Inc. stock aren't ruling out issuing a subpoena to force her to appear on Capitol Hill. "It may be the only means to get her to come forward and tell her Source: www.baltimoresun.com FDA gives priority review to Sanofi's Multaq - BusinessWeek U.S. regulators have given priority review status to Sanofi-Aventis' Multaq treatment for irregular heartbeat, a ruling that could help speed the drug's launch, the French pharmaceutical company said Friday. Drugs given the Food and Drug Source: www.businessweek.com FDA Extends Review Timeline for Ustekinumab Biologic License - Forbes HORSHAM, Pa., Aug. 8 /PRNewswire/ -- Centocor, Inc., today announced that the U.S. Food and Drug Administration (FDA) has extended the review timeline for the Biologic License Application for ustekinumab, a subcutaneous biologic therapy, by three Source: www.forbes.com FDA Approves First Generic Divalproex Sodium to Treat Seizures, Migraine Headaches and Bipolar Disorder FDA Approves First Generic Divalproex Sodium to Treat Seizures, Migraine Headaches and Bipolar Disorder
The U.S. Food and Drug Administration today approved the first generic version of Depakote delayed-release tablets (divalproex sodium). Depakote is approved by the FDA for the treatment of seizures, bipolar disorder and migraine headaches. Pet Food Products Seized at PETCO Distribution Center Consumers who bought animal food products from PETCO in 16 states should take certain precautions Strengthening the Advisory Committee Process FDA is strengthening the process by which it gets expert, independent advice that affects new treatments and other products available to consumers. Stronger Warnings Requested for Fluoroquinolones FDA has notified manufacturers of fluoroquinolones that a boxed warning on the increased risk of tendinitis and tendon rupture is necessary. UPDATE 2-Sanofi boosted by priority review for Multaq drug - Reuters UPDATE 2-Sanofi boosted by priority review for Multaq drug - Reuters
LONDON, Aug 8 (Reuters) - Sanofi-Aventis's (SASY.PA: Quote , Profile , Research , Stock Buzz ) experimental heart drug Multaq, which some analysts believe could be worth more than $2 billion in sales a year, is to get a priority review from the U.S Source: www.reuters.com Brasher: Unsafe food leads to calls for increased FDA authority more - Des Moines Register Washington, D.C. — Toys were first. Food may be next on the agenda for Congress in a wave of government regulation. Congress has overwhelmingly agreed to give the Consumer Product Safety Commission more money and authority to regulate children's Source: www.desmoinesregister.com When dinner makes you sick - Boston Globe HOW MANY more times will vegetable growers have to plow under their crops after a food poisoning incident, since consumers stop buying the suspect produce and federal officials have no quick way to trace contamination to its source? Growers lost $250 Source: www.boston.com Patients taking Zocor or Vytorin and a heart rhythm drug can suffer - Newsday WASHINGTON (AP) _ Patients taking some common medications for high cholesterol and irregular heart beats can suffer severe muscle damage because of a problem in the way the drugs interact, the government warned on Friday. The Food and Drug Source: www.newsday.com FDA: Some cholesterol and heart drugs don't mix - Hanford Sentinel WASHINGTON - Patients taking some common medications for high cholesterol and irregular heart beats can suffer severe muscle damage because of a problem in the way the drugs interact, the government warned on Friday. The Food and Drug Administration Source: www.hanfordsentinel.com US extends review of J&J psoriasis drug by 3 mos - Forbes NEW YORK (Reuters) - U.S. health regulators have extended their review of Johnson & Johnson's experimental psoriasis drug, ustekinumab, by three months, the company's Centocor (other-otc: CNTO.PK - news - people ) unit said Friday. The U.S. Food and Source: www.forbes.com Johnson & Johnson drug review delayed by 3 months - Forbes Johnson & Johnson's Centocor unit said Friday the Food and Drug Administration will take an additional three months to review an application for the experimental psoriasis drug ustekinumab. The company said the review could now run through December Source: www.forbes.com |
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