August 23, 2008Amgen’s Nplate ITP-Treating Drug Gets FDA Approval - Eflux Media Amgen’s Nplate ITP-Treating Drug Gets FDA Approval - Eflux Media
Nplate, Amgen’s drug destined for patients suffering from a rare blood disorder called chronic immune thrombocytopenic purpura (ITP), was approved by the Food and Drug Administration on Friday. The administration labeled it as safe and effective Source: www.efluxmedia.com FDA to Review Data on Cholesterol Drug and Cancer - CNBC U.S. Food and Drug Administration officials plan to review recently publicized data that showed a higher rate of cancer in patients taking Merck and Schering-Plough's cholesterol drug Vytorin. The agency, in a notice posted on its Web site on Source: www.cnbc.com FDA Needs Nine More Months to Study Vytorin, Cancer Link - Medheadlines.com Questions have arisen over the past several months as to the efficacy and safety of the popular cholesterol-lowering prescription drug, Vytorin, which is a combination of ezetimibe and simvastatin. The US Food and Drug Administration (FDA) issued a Source: medheadlines.com FDA to permit irradiation of spinach, lettuce - San Francisco Gate FDA to permit irradiation of spinach, lettuce - San Francisco Gate
Friday, August 22, 2008 The Food and Drug Administration is amending the food-additive regulations to provide what it calls the safe use of ionizing radiation for just the two leafy greens. The FDA also has received petitions seeking permission to Source: www.sfgate.com FDA approves irradiating spinach, lettuce to kill germs - Los Angeles Times The FDA determined that irradiation indeed can kill food-poisoning germs and even lengthen the greens' shelf life without compromising the safety or nutrient value of raw spinach and lettuce. The new regulation goes into effect Friday. The FDA says Source: www.latimes.com FDA Okays Amgen’s Nplate for treating rare blood disorder - Food Consumer Saturday August 23, 2008 (foodconsumer.org) -- The Food and Drug Administration on Friday Aug. 22 announced its approval of Nplate (romiplostim) manufactured by Amgen, Inc. of Thousand Oaks, California as a bone marrow stimulator to treat immune Source: foodconsumer.org FDA OKs zapping greens for safety - CNN WASHINGTON (AP) -- Consumers worried about salad safety may soon be able to buy fresh spinach and iceberg lettuce zapped with just enough radiation to kill E. coli and a few other germs. The FDA said irradiation doesn't compromise the safety or Source: sportsillustrated.cnn.com FDA to let spinach, lettuce be X-rayed to combat E. coli - Detroit Free Press WASHINGTON -- The government will allow food producers to start zapping fresh spinach and iceberg lettuce with just enough radiation to kill E. coli and other dangerous germs, a key safety move amid increasing outbreaks from raw produce. Irradiated Source: www.freep.com UPDATE 2-U.S. FDA approves Amgen's blood platelet booster - Reuters WASHINGTON, Aug 22 (Reuters) - Amgen Inc (AMGN.O: Quote , Profile , Research , Stock Buzz ) drug Nplate is safe and effective for treating a rare clotting disorder that can cause dangerous bleeding, the U.S. Food and Drug Administration said on Source: www.reuters.com 2nd UPDATE:FDA Reviews Vytorin Studies,Yet To See Cancer Link - CNN Money WASHINGTON -(Dow Jones)- The U.S. Food and Drug Administration on Thursday said interim data from two large, ongoing trials involving the cholesterol- lowering drug Vytorin show no increased risk of cancer. The FDA is reviewing a recent study, called Source: money.cnn.com FDA to allow food producers to irradiate spinach, lettuce - USA Today The Food and Drug Administration has approved use of irradiation on spinach and lettuce to kill dangerous bacteria, but companies may have a tough time selling the idea to consumers. The FDA's decision, effective today, adds iceberg lettuce and Source: www.usatoday.com FDA Allows Irradiation of Some Produce - Washington Post Food producers can now use radiation to kill bacteria on fresh spinach and iceberg lettuce because of a new Food and Drug Administration ruling meant to help head off outbreaks of foodborne illness. This is the first time the agency has allowed Source: www.washingtonpost.com FDA Approves Nplate(TM) for Long-Term Treatment of Adult Chronic ITP - MSN MoneyCentral Amgen Inc. AMGN today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Nplate ™ (romiplostim), the first and only platelet producer for the treatment of thrombocytopenia in splenectomized (spleen removed) and Source: news.moneycentral.msn.com Vivitrol (naltrexone) Vivitrol (naltrexone)
Serious injection site reactions may occur with the use of injectable naltrexone. Erythropoiesis Stimulating Agents (ESAs) - Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp) UPDATE - Dear Healthcare Professional letter added. 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. Desmopressin Acetate (marketed as DDAVP Nasal Spray, DDAVP Rhinal Tube, DDAVP, DDVP, Minirin, and Stimate Nasal Spray) UPDATE - December 2007 Dear Healthcare Professional Letter and revised labeling (re: hyponatremia and seizures) added to previous alert. Drug Shortage: Drug to be Discontinued; Revex (Nalmefene HCl Injection) Baxter has discontinued Revex production. FDA: Irradiating spinach, lettuce OK to kill germs - Atlanta Journal Constitution FDA: Irradiating spinach, lettuce OK to kill germs - Atlanta Journal Constitution
WASHINGTON — Consumers worried about salad safety may soon be able to buy fresh spinach and iceberg lettuce zapped with just enough radiation to kill E. coli and a few other germs. The Food and Drug Administration on Friday will issue a regulation Source: www.ajc.com FDA to Review Data on Cholesterol Drug and Cancer - CNBC U.S. Food and Drug Administration officials plan to review recently publicized data that showed a higher rate of cancer in patients taking Merck and Schering-Plough's cholesterol drug Vytorin. The agency, in a notice posted on its Web site on Source: www.cnbc.com FDA Approves Nplate(TM) for Long-Term Treatment of Adult Chronic ITP - MSN MoneyCentral Amgen Inc. AMGN today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Nplate ™ (romiplostim), the first and only platelet producer for the treatment of thrombocytopenia in splenectomized (spleen removed) and Source: news.moneycentral.msn.com Drug Shortage: MVI Adult Injectable Drug Shortage: MVI Adult Injectable
Hospira information updated. 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. 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. Drug Shortages: Drugs to be Discontinued; Geref Diagnostic EMD Serono has made a business decision to discontinue this product. 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 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. 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 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. August 22, 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. Drug Shortage: Fentanyl transdermal patch Availability information updated. 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). 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... 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 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. Interior Alaska Fish Processors, Inc. Recalls Santa's Smokehouse Brand Smoked Keta Salmon (August 13) Interior Alaska Fish Processors, Inc. Recalls Santa's Smokehouse Brand Smoked Keta Salmon (August 13)
The recalled product was sold in random weight portions and packaged in clear plastic vacuum sealed bags with the Santa's Smokehouse "teriyaki style smoked keta salmon" label on it. The only batch subject to the recall will be labeled with the batch number '637', found on the Santa's Smokehouse label. S and M (USA) Enterprise Corp. Issues Alert on Undeclared Sulfites in Grove Grow Notes Brand Dried Bamboo Fungus Veiled Lady (August 12) The recall was initiated after routine sampling by New York State Department of Agriculture and Markets food inspectors and subsequent analysis by Food Laboratory personnel revealed the presence of sulfites in Grove Grow Notes brand Dried Bamboo Fungus Veiled Lady which were not declared on the label. The consumption of 10 milligrams of sulfites per serving has been reported to elicit severe reaction in some asthmatics. Anaphylactic shock could occur in certain sulfite sensitive individuals upon ingesting 10 milligrams or more of sulfites 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. 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. 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 ... 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 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. 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. 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. Recalls 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... Vivitrol (naltrexone) Serious injection site reactions may occur with the use of injectable naltrexone. 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. Fentanyl Transdermal System CII Patches UPDATE - Voluntary recall because one lot of the product contained patches leaking fentanyl gel. Byetta (exenatide) UPDATE - Since October 2007, FDA has received reports of 6 cases of hemorrhagic or necrotizing pancreatitis in patients in taking Byetta. 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. July 2008 Monthly Safety Labeling Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. FDA Warns Consumers 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. FDA investigates possible Vytorin link to cancer - Miami Herald FDA investigates possible Vytorin link to cancer - Miami Herald
WASHINGTON Federal drug safety regulators said Thursday they are investigating whether the cholesterol-lowering drug Vytorin can increase patients' risk of developing cancer. However, the Food and Drug Administration said patients should not stop Source: www.miamiherald.com August 21, 2008Resolved Drug Shortage: Digoxin oral tablets Resolved Drug Shortage: Digoxin oral tablets
See website for more information about this resolved shortage. 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. Drug Shortages: Current Drug Shortages; Phospholine Iodide, Ophthalmic solution See Web site for additional information on this current drug shortage 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. Drug Shortage: Drug to be Discontinued; Revex (Nalmefene HCl Injection) Baxter has discontinued Revex production. S and M (USA) Enterprise Corp. Issues Alert on Undeclared Sulfites in Grove Grow Notes Brand Dried Bamboo Fungus Veiled Lady (August 12) The recall was initiated after routine sampling by New York State Department of Agriculture and Markets food inspectors and subsequent analysis by Food Laboratory personnel revealed the presence of sulfites in Grove Grow Notes brand Dried Bamboo Fungus Veiled Lady which were not declared on the label. The consumption of 10 milligrams of sulfites per serving has been reported to elicit severe reaction in some asthmatics. Anaphylactic shock could occur in certain sulfite sensitive individuals upon ingesting 10 milligrams or more of sulfites FDA Approves First Drug for Treatment of Chorea in Huntington's Disease FDA Approves First Drug for Treatment of Chorea in Huntington's Disease
The U.S. Food and Drug Administration has approved Xenazine (tetrabenazine) for the treatment of chorea in people with Huntington's disease. Chorea is the jerky, involuntary movement that occurs in people with this disease. FDA reports new deaths with diabetes drug - Chicago Tribune FDA reports new deaths with diabetes drug - Chicago Tribune
WASHINGTON - Federal regulators are working on a stronger warning label for a widely used diabetes drug after new deaths were reported despite earlier warnings. The Food and Drug Administration says it has received six new reports of patients Source: www.chicagotribune.com Before outbreak, dirty chiles rejected often - San Francisco Gate Tuesday, August 19, 2008 Yet no larger action was taken. Food and Drug Administration officials insisted as recently as last week that they were surprised by the outbreak because Mexican peppers had not been spotted as a problem before. But an Source: www.sfgate.com FDA reports deaths with diabetes drug Byetta - Associated Press WASHINGTON (AP) -- Federal regulators are working on a stronger label for a widely used diabetes drug marketed by Amylin Pharmaceuticals Inc. and Eli Lilly & Co. after deaths were reported with the medication despite earlier government warnings. The Source: hosted.ap.org FDA warns General Electric over lax record keeping - International Herald Tribune WASHINGTON : Federal regulators have warned General Electric Co. over lax quality control standards at a plant that makes computer software for medical imaging. The warning letter from the Food and Drug Administration released Tuesday lists a dozen Source: www.iht.com August 20, 2008Barr subsidiary gets final FDA OK for generic version of Pfizer's - Forbes Barr subsidiary gets final FDA OK for generic version of Pfizer's - Forbes
BOSTON (Thomson Financial) - Barr Pharmaceuticals Inc. Wednesday said its subsidiary Pliva-Lachema a.s. has received final approval from the U.S. Food and Drug Administration for its generic version of Pfizer Inc. 's Aredia injection. The company Source: www.forbes.com UPDATE 1-PreMD shares plunge on FDA ruling - Reuters TORONTO, Aug 18 (Reuters) - PreMD Inc (PMD.TO: Quote , Profile , Research , Stock Buzz ) lost more than half of its value on Monday after the U.S. Food and Drug Administration upheld an earlier decision to not approve expanded use of its skin Source: www.reuters.com St. Jude says FDA approves Puerto Rico facility - CNN Money NEW YORK (Associated Press) - St. Jude Medical Inc. said Wednesday the U.S. Food and Drug Administration has approved a facility in Arecibo, Puerto Rico, that will make pacemakers and cardiac leads. The medical device maker said it will start making Source: money.cnn.com FDA: Do Not Eat Certain Mussel Products From Bantry Bay Seafood - eMaxHealth.com 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 Source: www.emaxhealth.com FDA seeks stronger warning for diabetes drug - CNN WASHINGTON (AP) -- Federal regulators are working on a stronger label for a widely used diabetes drug marketed by Amylin Pharmaceuticals Inc. and Eli Lilly & Co. as deaths continue to be reported despite earlier government warnings. The FDA Source: www.cnn.com Behind the FDA's 'black box' warnings - Los Angeles Times TWO GROUPS of drugs were under the Food and Drug Administration spotlight last month. Both have been associated with rare but serious side effects, and both were candidates for a "black box" warning, the strongest the FDA issues short of taking a Source: www.latimes.com Medical Policy Guideline for Trofile(TM) Established By Wellpoint, Inc - MSN MoneyCentral SOUTH SAN FRANCISCO, Calif. , Aug. 20 /PRNewswire-FirstCall/ -- Monogram Biosciences, Inc. MGRM today announced that Wellpoint, Inc. has established a national Medical Policy Guideline for Monogram's Trofile Assay. Wellpoint's guidelines provide that Source: news.moneycentral.msn.com Lpath Receives $6.4 Million Equity Financing - MSN MoneyCentral Lpath, Inc. (OTCBB: LPTN), the category leader in therapeutic agents against bioactive lipids, reported the receipt of approximately $6.4 million in a private placement of unregistered shares of Class A common stock. The shares were issued at a price Source: news.moneycentral.msn.com Amylin-Lilly Drug Gets FDA Warning - Street.Com Shares of Amylin AMLN and Eli Lilly stumbled Monday after regulators warned of two deaths possibly related to the companies' Byetta diabetes drug. Shares of Amylin fell 16%, to $28.86, while its partner Eli Lilly were off by 1.7%, at $47.94. More Source: www.thestreet.com FDA reports new deaths with diabetes drug Byetta - Chicago Tribune WASHINGTON - Federal regulators are working on a stronger label for a widely used diabetes drug marketed by Amylin Pharmaceuticals Inc. and Eli Lilly & Co. as deaths continue to be reported despite earlier government warnings. The Food and Drug Source: www.chicagotribune.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. 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. 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. 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. 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. Simvastatin Used With Amiodarone Risk of rhabdomyolysis when simvastatin is used with amiodarone, particularly with simvastatin doses greater than 20 mg daily. Grande Produce, LTD.CO Recalls Jalapeno Peppers, Serrano Peppers, and Avocados Because of Possible Health Risk (July 19) The Jalapeno Peppers, Serrano Peppers and Avocados were distributed to the following states: TX, DE, NC, GA, OK, IA, MN, IL, FL, IN, MD, NY, MS, AR, KS, and KY. The avocados being recalled were shipped in boxes labeled "Frutas Finas de Tancitaro HASS Avocados, Produce of Mexico," all sizes, with lot number HUE08160090889. The Jalapeno Peppers and Serrano peppers being recalled were shipped in 35lb. plastic crates with no brand name or label. 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. 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. Fentanyl Transdermal System CII Patches UPDATE - Voluntary recall because one lot of the product contained patches leaking fentanyl gel. 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. Grande Produce, LTD.CO Recalls Jalapeno Peppers, Serrano Peppers, and Avocados Because of Possible Health Risk (July 19) The Jalapeno Peppers, Serrano Peppers and Avocados were distributed to the following states: TX, DE, NC, GA, OK, IA, MN, IL, FL, IN, MD, NY, MS, AR, KS, and KY. The avocados being recalled were shipped in boxes labeled "Frutas Finas de Tancitaro HASS Avocados, Produce of Mexico," all sizes, with lot number HUE08160090889. The Jalapeno Peppers and Serrano peppers being recalled were shipped in 35lb. plastic crates with no brand name or label. 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. August 19, 2008Amylin-Lilly Drug Gets FDA Warning - Street.Com Amylin-Lilly Drug Gets FDA Warning - Street.Com
Shares of Amylin AMLN and Eli Lilly stumbled Monday after regulators warned of two deaths possibly related to the companies' Byetta diabetes drug. Shares of Amylin fell 16%, to $28.86, while its partner Eli Lilly were off by 1.7%, at $47.94. More Source: www.thestreet.com FDA 101: Biological Products FDA 101: Biological Products
Basic facts about biologics, products that replicate natural biologic substances such as enzymes, antibodies, or hormones in our bodies. 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. 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. 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. Domega International Co., Ltd. Issues an Alert on Undeclared Sulfites in Korica Brand Mut Gung Sweetened Ginger (July 16) 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. 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. Drug Shortage: Drug to be Discontinued; Revex (Nalmefene HCl Injection) Baxter has discontinued Revex production. 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. Drug Shortage: Fentanyl transdermal patch Availability information updated. India's Unichem Labs gets U.S. FDA approval for hydrochlorothiazide - Forbes India's Unichem Labs gets U.S. FDA approval for hydrochlorothiazide - Forbes
MUMBAI (Thomson Financial) - India-based Unichem Laboratories Ltd. said it has received an approval from the U.S. Food and Drug Administration (FDA) for its hydrochlorothiazide tablets. Hydrochlorothiazide is a thiazide diuretic that helps prevent Source: www.forbes.com 6 people on diabetes drug fall ill; 2 die - San Diego Union-Tribune The Food and Drug Administration yesterday reported that six people with type 2 diabetes, who were taking Amylin Pharmaceuticals' drug Byetta to control their blood sugar, developed a severe inflammation of the pancreas. Two of the six people died Source: www.signonsandiego.com PreMD Inc. - FDA Upholds Previous NSE Decision - Forbes TORONTO, Aug. 18 /PRNewswire-FirstCall/ - Predictive medicine company PreMD Inc. (TSX: PMD - News; Amex: PME - News) today announced that the U.S. Food and Drug Administration ("FDA") has upheld their decision regarding the company's not Source: www.forbes.com Huntington’s Disease – FDA approval of Tetrabenazine Drug - Best Syndication [Best Syndication News] Tetrabenazine was approved by the US Food and Drug Administration which is the first drug that has been approved in the US for treating Huntington’s disease. Currently there is no cure for Huntington’s disease and is a Source: www.bestsyndication.com FDA reports new deaths with diabetes drug Byetta - Boston Globe WASHINGTON— Federal regulators are working on a stronger warning label for a widely used diabetes drug after new deaths were reported despite earlier warnings. The Food and Drug Administration says it has received six new reports of patients Source: www.boston.com Feds want stronger warning about diabetes drug - San Francisco Gate Tuesday, August 19, 2008 The Food and Drug Administration said Monday it has received six new reports of patients developing a dangerous form of pancreatitis while taking Byetta. Two died and four are recovering. Regulators stressed that patients Source: www.sfgate.com August 18, 2008Stronger label sought for diabetes drug Byetta - International Herald Tribune Stronger label sought for diabetes drug Byetta - International Herald Tribune
WASHINGTON : Federal regulators are working on a stronger label for a widely used diabetes drug marketed by Amylin Pharmaceuticals and Eli Lilly & Company after deaths continue to be reported despite earlier government warnings. The Food and Drug Source: www.iht.com FDA reports deaths with diabetes drug Byetta - Yahoo News WASHINGTON - Federal regulators are working on a stronger label for a widely used diabetes drug marketed by Amylin Pharmaceuticals Inc . and Eli Lilly & Co. after deaths were reported with the medication despite earlier government warnings. The Food Source: news.yahoo.com FDA says chemical found in plastic bottles is safe - Boston Globe FDA says chemical found in plastic bottles is safe - Boston Globe
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 yesterday. Food and Drug Administration scientists Source: www.boston.com FDA: Six Pancreatitis Cases In Byetta Patients Since October - CNN Money NEW YORK -(Dow Jones)- The Food and Drug Administration has received reports of six cases of pancreatitis, including two deaths, in patients taking diabetes drug Byetta, co-marketed by Amylin Pharmaceuticals Inc. (AMLN) and Eli Lilly & Co. (LLY Source: money.cnn.com UPDATE 1-PreMD shares plunge on FDA ruling - Reuters TORONTO, Aug 18 (Reuters) - PreMD Inc (PMD.TO: Quote , Profile , Research , Stock Buzz ) lost more than half of its value on Monday after the U.S. Food and Drug Administration upheld an earlier decision to not approve expanded use of its skin Source: www.reuters.com FDA Reports New Deaths With Diabetes Drug Byetta - CBS News (AP) Federal regulators are working on a stronger label for a widely used diabetes drug marketed by Amylin Pharmaceuticals Inc. and Eli Lilly & Co. after deaths continue to be reported despite earlier government warnings. The Food and Drug Source: www.cbsnews.com FDA reports new deaths with diabetes drug - Chicago Tribune WASHINGTON - Federal regulators are working on a stronger warning label for a widely used diabetes drug after new deaths were reported despite earlier warnings. The Food and Drug Administration says it has received six new reports of patients Source: www.chicagotribune.com UPDATE: Medco Health, FDA To Study Genetic Testing For Drugs - CNN Money Pharmacy-benefits manager Medco Health Solutions Inc. (MHS) has entered into a partnership with the U.S. Food and Drug Administration to study the role of patients' genetic makeup in prescribing medications, a collaboration aimed at expanding the Source: money.cnn.com PreMD Inc. - FDA Upholds Previous NSE Decision - Forbes PreMD Inc. - FDA Upholds Previous NSE Decision - Forbes
TORONTO, Aug. 18 /PRNewswire-FirstCall/ - Predictive medicine company PreMD Inc. (TSX: PMD - News; Amex: PME - News) today announced that the U.S. Food and Drug Administration ("FDA") has upheld their decision regarding the company's not Source: www.forbes.com Biotest Diagnostics Receives FDA Clearance for Full Line of - PR Newswire ROCKAWAY, N.J., Aug. 18 /PRNewswire/ -- Biotest Diagnostics Corporation (Biotest) -- the U.S. subsidiary of German-based Biotest AG, a worldwide supplier of traditional and automated blood bank solutions -- announces that it has received final Source: sev.prnewswire.com Science FDA Concludes Nalgene Products Safe, Critics Not Convinced - DailyTech A variety of polycarbonate bottles, including the popular Nalgene shatter-free bottles contain the chemical bisphenol A. In sufficient quanitities the chemical is believed to disrupt hormones, but the FDA concludes in an early report that the levels Source: www.xbitlabs.com FDA Approves First Drug for Treatment of Chorea in Huntington’s - WebWire The U.S. Food and Drug Administration has approved Xenazine (tetrabenazine) for the treatment of chorea in people with Huntington’s disease. Chorea is the jerky, involuntary movement that occurs in people with this disease. Xenazine is a new drug Source: www.webwire.com The FDA Is Trying To Avoid A National Crisis - Eflux Media The U.S. Food and Drug Administration is currently dealing with a major problem on a national level. The number of news and reports about narcotic-related deaths is at an all-time high and the situation is in disparate need of a rapid fix. The FDA is Source: www.efluxmedia.com Daily Snapshot - CNN Daily Snapshot - CNN
1 Liu Xiang pulls out of hurdles 2 Musharraf to address nation 3 The myth of 'Miss Kim' 4 Hundreds flee Grand Canyon flood 5 Lawmaker hints at stay in Georgia 6 Town sends plea for 'ugly women' 7 Iran media: Iran test-fires rocket 8 Endorsements pure Source: edition.cnn.com Researchers pursue artificial heparin - Philadelphia Inquirer Robert J. Linhardt says he believes he has found a way to manufacture the blood thinner heparin that would prevent a repetition of the recent contamination crisis linked to at least 95 patient deaths nationwide. Heparin is currently derived from pig Source: www.philly.com FDA says controversial bisphenol A is safe - San Francisco Gate Saturday, August 16, 2008 Food and Drug Administration scientists said the trace amounts of bisphenol A that leach out of food containers are not a threat to infants or adults. The agency acknowledged that more research is needed to fully understand Source: www.sfgate.com FDA says chemical found in plastic bottles is safe - NWITimes.com 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: nwitimes.com FDA: BPA Safe In Food Containers - Tampa Bay Online WASHINGTON - 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 Friday by the Food and Drug Source: www2.tbo.com Cambridge Laboratories Announces FDA Approval of XENAZINE(R - EIN News LONDON, August 18 /PRNewswire/ -- Cambridge Laboratories Group Limited ("Cambridge"), the privately owned specialty pharmaceutical company, announces today that XENAZINE(R) (tetrabenazine), the first and only product for the treatment of chorea Source: www.einnews.com The FDA Is Trying To Avoid A National Crisis - Eflux Media The U.S. Food and Drug Administration is currently dealing with a major problem on a national level. The number of news and reports about narcotic-related deaths is at an all-time high and the situation is in disparate need of a rapid fix. The FDA is Source: www.efluxmedia.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 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: cnn.com Critical stage for biotechs - Baltimore Sun A number of Maryland's biotechnology companies will have prospective new drugs in their final round of clinical testing this year, a key stage for some in their efforts to fully evolve from research organizations into market-driven businesses Source: www.baltimoresun.com FDA approves 1st drug for Huntington's disease - Newsday FDA approves 1st drug for Huntington's disease - Newsday
Federal drug regulators Friday approved a medication to treat a major symptom of Huntington's disease, marking the first time since the disorder was first described in a Long Island family 136 years ago that any kind of treatment has been available Source: www.newsday.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 Agency: Chemical OK in food containers - Seattle Times WASHINGTON — 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 Source: seattletimes.nwsource.com FDA says chemical found in plastic bottles is safe - Boston Globe 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 yesterday. Food and Drug Administration scientists Source: www.boston.com Lawsuits help guarantee drug safety, doctors say - Seattle Post Intelligencer 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 Source: seattlepi.nwsource.com Huntington's drug wins FDA approval - Seattle Times In remembrance: Relatives, friends and firefighters on Friday mourn the nine men killed last week when a firefighting helicopter crashed in Northern California. More than 3,000 people attended the memorial at the Jackson County Fairgrounds near Source: seattletimes.nwsource.com Drug Shortages: Drugs to be Discontinued; Geref Diagnostic Drug Shortages: Drugs to be Discontinued; Geref Diagnostic
EMD Serono has made a business decision to discontinue this product. Drug Shortage: MVI Adult Injectable Hospira information updated. 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. 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. August 17, 2008Roxane 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). Current Drug Shortage: Proglycem (diazoxide) oral suspension Current Drug Shortage: Proglycem (diazoxide) oral suspension
Teva is managing inventory and can provide product from their emergency supply. Orders for Proglycem can be made during regular business hours (8am to 5pm Eastern, Monday through Friday) by calling Customer Service at 800-545-8800. Emergency requests can be made after hours by calling 800-795-2652 Simvastatin Used With Amiodarone Risk of rhabdomyolysis when simvastatin is used with amiodarone, particularly with simvastatin doses greater than 20 mg daily. 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. Drug Shortages: Drugs to be Discontinued; Geref Diagnostic Drug Shortages: Drugs to be Discontinued; Geref Diagnostic
EMD Serono has made a business decision to discontinue 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. 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 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 1st US drug for Huntington's disease wins approval - Miami Herald 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 medication Source: www.miamiherald.com FDA concludes bisphenol A chemical used in baby bottles, canned food - Newsday 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.newsday.com The newest generation of drugs: Who can afford them? - Seattle Times Copaxone is the only drug that has eased Sally Garcia's multiple sclerosis symptoms, but she can't afford the cost on her own. DEAN RUTZ / THE SEATTLE TIMES "I'll be this 90-year-old lady fighting for her Copaxone," predicts Sally Garcia, shown Source: seattletimes.nwsource.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 1st US Drug For Huntington's Disease Wins Approval - CBS News (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 medication Source: www.cbsnews.com Doctors might face narcotics education - Columbus Dispatch Should doctors be required to undergo special education before prescribing powerful narcotics? The Food and Drug Administration might soon recommend that they do so, but such a move would most likely prove controversial. "I think it is a good idea Source: www.dispatch.com Jack Distribution, LLC. Issues a Voluntary Nationwide Recall of all Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules, Products Marketed as Dietary Supplements, Containing an Undeclared Ingredient(July 28) Jack Distribution, LLC. Issues a Voluntary Nationwide Recall of all Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules, Products Marketed as Dietary Supplements, Containing an Undeclared Ingredient(July 28)
Jack Distribution, LLC, and its wholesale distributors G and N works, Inc., and Devine Distribution, Inc., announced today that they are conducting a voluntary nationwide recall of all lot numbers of the company's supplement products sold under the brand names Rize 2 The Occasion and Rose 4 Her. New lots of Rize 2 and Rose 4 her (not subject to this recall) will contain lot numbers beginning in "BL". 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. |
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