November 8, 2008FDA Statement on Release of Bisphenol A (BPA) Subcommittee Report FDA Statement on Release of Bisphenol A (BPA) Subcommittee Report
The subcommittee report to the Science Board raises important questions regarding the draft safety assessment, and the FDA looks forward to the review of the subcommittee's report by the Science Board on Oct 31. Medtronic Neuromodulation INDURA One-Piece Intrathecal Catheters, Sutureless Pump Connector Revision Kit, Intrathecal Catheter Pump Segment Revision Kit Class I Recall because of potential misconnections of the Medtronic sutureless connector catheters from the catheter port on the pump. FDA Approves Toviaz, a New Drug to Treat Overactive Bladder The U.S. Food and Drug Administration has approved a new drug to help patients suffering from overactive bladder (OAB). Toviaz (fesoterodine fumarate) works by relaxing the smooth muscle tissue of the bladder, thus reducing the urinary frequency, urge to urinate, and sudden urinary incontinence (leakage of urine), that are characteristic symptoms of OAB. Transvaginal Placement of Surgical Mesh Serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse and stress urinary incontinence. Keeping Watch Over Direct-to-Consumer Ads FDA regulates direct-to-consumer advertising for prescription drugs, working to ensure that ads are truthful, balanced, and accurate. Outsmarting Poison Ivy and Other Poisonous Plants Poison ivy and other poisonous plants are a hazard all year round. Here are tips for preventing and treating the itchy rash and blisters. ETHEX Corporation Voluntarily Recalls Three Lots of Dextroamphetamine Sulfate 5mg Tablets Due to the Potential for Oversized Tablets (October 15) ETHEX Corporation Voluntarily Recalls Three Lots of Dextroamphetamine Sulfate 5mg Tablets Due to the Potential for Oversized Tablets (October 15)
ETHEX Corporation announced today that it has voluntarily recalled three specific lots (77946, 81141 and 81142) of Dextroamphetamine Sulfate 5 mg tablets, as a precaution, due to the possible presence of oversized tablets. Oversized tablets may contain as much as about twice the labeled amount of the active ingredient. The recalled lots were distributed by ETHEX Corporation under an "ETHEX" label between January 2007 and May 2008. The 5 mg product is an orange round tablet debossed with "ETHEX" and "311" on one side. HHS/FDA Grants Tentative Approval for 75th Generic Anti-Retroviral Drug as Part of President's Emergency Plan for AIDS Relief Marketed by Macleods Pharmaceuticals, Ltd, of Kachigam, Daman, in the Republic of India, the 75th drug is 150 milligram and 300 milligram tablets of generic lamivudine, a nucleoside analog reverse-transcriptase inhibitor (nRTI), which blocks an enzyme called reverse transcriptase, important to HIV production. HIV-infected patients who take lamivudine with other anti-HIV treatments develop less opportunistic infections. Everlasting Distributors Inc. Issues a Nationwide Recall of Fresh and Crispy Jacobina Biscuits Because of Possible Health Risks (October 29) Everlasting Distributors Inc., Bayonne NJ is initiating a nationwide recall of all their 3.88oz (110gm) packages of Fresh and Crispy Jacobina Biscuits because it may be contaminated with Melamine. General Mills Issues Voluntary Class One Recall Involving One Day's Production of Progresso Hearty Tomato Soup (October 31) General Mills is voluntarily recalling a single day's production of Progresso Hearty Tomato soup because of a product labeling issue. Product produced on this date may have been mislabeled, and may contain allergens not listed on the ingredient label, specifically egg, milk, and soy. Nebion HLX-8 Magnetic Resonance Device Device recalled because it was not approved by FDA, lacked safety and effectiveness data, and was not manufactured under current good manufacturing practices. FDA Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes FDA Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes
The U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death. GlaxoSmithKline diabetes drug faces more criticism - Philadelphia Inquirer GlaxoSmithKline diabetes drug faces more criticism - Philadelphia Inquirer
Two prominent consumer groups have warned that diabetes patients should not take GlaxoSmithKline P.L.C.'s drug Avandia because of dangerous side effects and the availability of equally effective treatments. Public Citizen, a consumer advocacy group Source: www.philly.com Tarceva maker: Study shows drug slows lung cancer - Newsday OSI Pharmaceuticals Inc. of Melville and its partners in an anti-lung cancer drug said Friday that results of a new study they conducted showed the medication, Tarceva, helped slow the progress of the disease when given immediately after chemotherapy Source: www.newsday.com Experts say FDA findings on compound misleading - CNN WASHINGTON (CNN) -- A panel of experts accused the Food and Drug Administration of creating "a false sense of security" with its assessment that a compound used to make food and beverage containers poses no immediate health risks. Bisphenol A is Source: www.cnn.com FDA clears Cephalon chemotherapy drug - Daily Local News No comments posted. WASHINGTON (AP) — Drugmaker Cephalon Inc. said Friday the Food and Drug Administration cleared its chemotherapy medicine Treanda to treat an additional form of cancer. The agency approved the drug for patients with recurring non Source: www.dailylocal.com FDA Warns of Dangers of Mexican Vanilla - Atlanta Journal Constitution FRIDAY, Oct. 31 (HealthDay News) -- So-called Mexican "vanilla" is often made with a toxic substance called coumarin and shouldn't be bought by consumers, the U.S. Food and Drug Administration warned this week. Coumarin is related to warfarin, which Source: www.ajc.com FDA urged to reassess BPA risk - Chicago Tribune WASHINGTON — The Food and Drug Administration made mistakes when determining that a widely used chemical found in baby bottles and other plastics was harmless, and the agency should redo its risk assessment, an FDA advisory panel said Friday as it Source: www.chicagotribune.com FDA accepts call for more research on BPA hazards - Minneapolis Star Tribune WASHINGTON - The Food and Drug Administration made mistakes when determining that a widely used chemical found in baby bottles and other plastics was harmless and the agency should redo its risk assessment, an FDA advisory panel ruled Friday. But the Source: www.startribune.com Supreme Court weighs drug lawsuits - San Francisco Gate Sunday, November 2, 2008 Seuferer's claim is one of many thousands of suspended cases across the country that hang on the decision of the U.S. Supreme Court in a pivotal case to be argued Monday. The question before the high court is whether patients Source: www.sfgate.com Drugmakers Support Janet Woodcock For U.S. FDA’s Top Job - Top News India With current FDA commissioner - Andrew von Eschenbach, who was appointed by President George Bush, planning to tender his resignation before Obama takes office, American drugmakers are lobbying President-elect Barack Obama to nominate Janet Woodcock Source: www.topnews.in HUA XIA Food Trade USA, Inc. Recalls YILI Brand Sour Milk Drink and YILI Brand Pure Milk Drink, Because of Possible Health Risk (October 10) HUA XIA Food Trade USA, Inc. Recalls YILI Brand Sour Milk Drink and YILI Brand Pure Milk Drink, Because of Possible Health Risk (October 10)
HUA XIA Food Trade USA, Inc. of Flushing, NY, is recalling YILI Brand Sour Milk Drink packaged in 250ml flexible paperboard boxes (all codes and all lots are affected) and YILI Brand Pure Milk Drink packaged in 250ml flexible paperboard boxes (all codes and all lots are affected) because it may be contaminated with melamine. FDA Seizes Contaminated Heparin from a Cincinnati Manufacturer The five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium were seized at the FDA's request by U.S. Marshals. These products, which were manufactured from material imported from China, had been found by the agency to be contaminated with over-sulfated chondroitin sulfate (OSCS), a substance that mimics heparin's anticoagulant activity. General Mills Issues Voluntary Class One Recall Involving One Day's Production of Progresso Hearty Tomato Soup (October 31) General Mills is voluntarily recalling a single day's production of Progresso Hearty Tomato soup because of a product labeling issue. Product produced on this date may have been mislabeled, and may contain allergens not listed on the ingredient label, specifically egg, milk, and soy. Recalls and Safety Alerts: Serious Fungal Infections with Humira, Cimzia, Enbrel and Remicade The manufacturers of Humira (adalimumab), Cimzia (certolizumab pegol), Enbrel (etanercept), and Remicade (infliximab) must strengthen warnings about the risk of developing opportunistic fungal infections from these drugs. These infections have been ... FDA Statement on Release of Bisphenol A (BPA) Subcommittee Report The subcommittee report to the Science Board raises important questions regarding the draft safety assessment, and the FDA looks forward to the review of the subcommittee's report by the Science Board on Oct 31. FDA Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes (November 5) The U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death. Thoratec Corporation Issues Worldwide Medical Device Correction of HeartMate II Left Ventricular Assist System (October 24) Thoratec Corporation is initiating a worldwide medical device correction of all serial numbers of the HeartMate II Left Ventricular Assist Systems (HM II LVAS) having Catalogue No. 1355 or 102139, which have been distributed since the beginning of clinical studies in November 2003. Over time, wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood pump with the System Controller may result in damage that could interrupt pump function, require reoperation to replace the pump and potentially result in serious injury or death. Lotte USA, Inc. Initiates Nationwide Recall of Koala's March Creme filled Cookies Lotte USA, Inc., Battle Creek, MI initiated a recall of all Koalas' March Cookies on September 29, 2008 because they were produced in China and they may be contaminated with melamine. The products are packaged in a plastic overwrap. Russell Stover Candies, Inc. Issues Hazelnut Allergy Alert for the 2 7/8 Oz Size Of Private Reserve Assorted Chocolates (October 9) The recalled product was distributed in the following states and cities: Texas, California, Louisiana, North Carolina, South Carolina, Virginia, Tennessee; Southaven, Mississippi; Billings, Montana; Sparks, Nevada; and Madison Heights, Michigan. An investigation determined 29 boxes of this candy may have been purchased by consumers, and up to another 188 boxes may have reached retail store locations. All the retail stores have been contacted to have the suspected product removed from the shelves. Mars Petcare US Issues Voluntary Recall of a Limited Number of Bags of SPECIAL KITTY Gourmet Sold at Wal-Mart locations in Fifteen States due to Potential Salmonella Contamination Mars Petcare US today announced a voluntary recall of a limited number of bags of SPECIAL KITTY Gourmet Blend dry cat food sold at Wal-Mart locations in Connecticut, Delaware, Massachusetts, Maryland, Maine, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Virginia, Vermont, and West Virginia. The pet food is being voluntarily recalled following a positive test result indicating a potential contamination with Salmonella. November 7, 2008FDA clears new drug for overactive bladder - Boston Globe FDA clears new drug for overactive bladder - Boston Globe
WASHINGTON— The Food and Drug Administration approved a new drug Friday to treat patients with overactive bladder, a disorder that causes frequent, uncontrollable urination. Toviaz, made by German manufacturer Schwarz Pharma , helps relax the Source: www.boston.com FDA approves new drug to treat overactive bladder - Xinhua News Agency WASHINGTON, Oct. 31 (Xinhua) -- The U.S. Food and Drug Administration has approved a new drug, Toviaz (fesoterodine fumarate), to help patients suffering from overactive bladder (OAB), according to a statement by the agency on Friday. The drug works Source: news.xinhuanet.com Woodcock Gains Support From Drugmakers for U.S. FDA's Top Job - Bloomberg Woodcock Gains Support From Drugmakers for U.S. FDA's Top Job - Bloomberg
Nov. 7 (Bloomberg) -- Janet Woodcock , a 22-year insider at the Food and Drug Administration, is the top choice of drugmakers who are lobbying for her to be named the agency's chief by President-elect Barack Obama , according to people associated Source: www.bloomberg.com Tarceva meets goal in first-line lung cancer trial - MSN MoneyCentral NEW YORK (AP) - OSI Pharmaceuticals Inc. and Genentech Inc. said their drug Tarceva met its main goal in a clinical trial, as it stopped the spread of advanced non-small cell lung cancer for significantly longer than a placebo. OSI and Genentech said Source: news.moneycentral.msn.com FDA chief bullish on medical, pharma progress - Philadelphia Inquirer Revolutionary medical advances will force dramatic changes in the ways that drugs are tested and approved and will require pharmaceutical companies to overhaul their businesses, the outgoing head of the U.S. Food and Drug Administration said today Source: www.philly.com Obama expected to bolster FDA oversight of imports - KIDK WASHINGTON (AP) - The Food and Drug Administration, bedeviled by a salmonella outbreak and tainted medicine from China, is likely to monitor imports and fresh produce more closely under an Obama administration. With President Bush no longer a Source: www.kidk.com InterMune 3Q loss narrows on Roche payment - Boston Globe BRISBANE, Calif.— Biotechnology company InterMune Inc. said late Thursday its third-quarter loss narrowed on higher revenue from a drug development partnership with Roche. The company lost $12.5 million, or 32 cents per share, compared with a loss Source: www.boston.com Dean Foods spent $95K lobbying government in 3Q - Forbes Dean Foods Co. spent $95,000 in the third quarter to lobby on food safety, agriculture and other issues, according to a recent disclosure report. The Dallas-based milk producer also lobbied on ethanol mandates, dairy and organic provisions, and more Source: www.forbes.com China closes herbal drug firm linked to deaths - HealthCentral.com BEIJING (Reuters) - China, battling to restore trust in its products amid a tainted milk scandal, has closed a local pharmaceutical company whose herbal injections have been linked to the deaths of three people. China last month expanded a product Source: www.healthcentral.com General Mills spent $192K lobbying gov't in 3Q - Forbes General Mills Inc. spent $192,000 in the third quarter to lobby on food safety, import inspections and other issues, according to a recent disclosure report. The Golden Valley, Minn.-based maker of Wheaties cereal and Pillsbury Toaster Strudel also Source: www.forbes.com Biotech Mailbag: Who Will Run FDA? - Street.Com The Biotech Mailbag is open. Dendreon ( DNDN Quote - Cramer on DNDN - Stock Picks ) was on the mind of Paul H. in the hours before Tuesday's presidential election was decided. He writes: What a difference a day makes for some people. Today we elect a Source: www.thestreet.com FDA Confiscates More Tainted Heparin - FOX News FDA Confiscates More Tainted Heparin - FOX News
WASHINGTON — Federal agents Thursday seized quantities of a contaminated blood thinner made in China from a small manufacturer in Cincinnati, officials said. The blood thinner heparin, given to patients undergoing heart surgery and kidney dialysis Source: www.foxnews.com FDA and Vouchers for Neglected Diseases: A Bad Idea Gone Bad - Huffingtonpost.com Are economic incentives necessary to get the private sector to do the right thing? Cities and states offer corporations tax breaks to locate in impoverished areas. Companies get tax breaks to beef up their research and development portfolios. In Source: www.huffingtonpost.com BioDelivery Sciences to Meet with FDA to Finalize Proposed REMS for - MSN MoneyCentral BioDelivery Sciences International, Inc., BDSI announced that a meeting with the Food and Drug Administration (FDA) is scheduled for November 17, 2008, to discuss its proposed Risk Evaluation and Mitigation Strategy (REMS) for ONSOLIS ™ . In August Source: news.moneycentral.msn.com Baltimore's Sharfstein mentioned as possible FDA commissioner - Baltimore Sun WASHINGTON - One of the names being floated to head the Food and Drug Administration is Baltimore public health chief Dr. Joshua Sharfstein. President-elect Barack Obama is being urged to move quickly to appoint an FDA commissioner. The agency has Source: www.baltimoresun.com Amgen Positioned to Deliver Attractive Growth Over Next Five Years - MSN MoneyCentral NEW YORK , Nov. 7 /PRNewswire-FirstCall/ -- At an Amgen AMGN meeting of about 200 securities analysts and investors in New York City today, several members of its senior management team outlined the Company's growth strategy, which includes Source: news.moneycentral.msn.com Obama expected to bolster FDA oversight of imports - KVAL WASHINGTON (AP) - The Food and Drug Administration, bedeviled by a salmonella outbreak and tainted medicine from China, is likely to monitor imports and fresh produce more closely under an Obama administration. With President Bush no longer a Source: www.kval.com FDA is expected to toughen stance - Statesman Journal WASHINGTON — The Food and Drug Administration, bedeviled by a salmonella outbreak and tainted medicine from China, is likely to monitor imports and fresh produce more closely under an Obama administration. With President Bush no longer a roadblock Source: www.statesmanjournal.com Woodcock Gains Support From Drugmakers for U.S. FDA's Top Job - Bloomberg Nov. 7 (Bloomberg) -- Janet Woodcock , a 22-year insider at the Food and Drug Administration, is the top choice of drugmakers who are lobbying for her to be named the agency's chief by President-elect Barack Obama , according to people associated Source: www.bloomberg.com Tarceva meets goal in first-line lung cancer trial - Boston Globe Tarceva meets goal in first-line lung cancer trial - Boston Globe
NEW YORK— OSI Pharmaceuticals Inc. and Genentech Inc. said their drug Tarceva met its main goal in a clinical trial, as it stopped the spread of advanced non-small cell lung cancer for significantly longer than a placebo. OSI and Genentech said Source: www.boston.com Insulin syringes sold at WalMart & Sam's Club recalled - WPVI WalMart and Sam's Club have issued a nationwide recall for nearly half a million single-use syringes that could pose a serious risk to diabetics. The Food and Drug Administration said the possibly mislabeled ReliOn syringes could lead to patients Source: abclocal.go.com Obama Expected To Bolster FDA Oversight Of Imports Save Email Print - WTAP Washington (AP) -- One of the names being floated to head the Food and Drug Administration is Cleveland Clinic Cardiologist and frequent agency critic Dr. Steven Nissen. President-elect Obama is being urged to move quickly to appoint an FDA Source: www.wtap.com China closes herbal drug firm linked to deaths - Reuters India BEIJING (Reuters) - China, battling to restore trust in its products amid a tainted milk scandal, has closed a local pharmaceutical company whose herbal injections have been linked to the deaths of three people. China last month expanded a product Source: in.reuters.com 2 new treatments take on migraines - Detroit Free Press 2 new treatments take on migraines - Detroit Free Press
Headaches distract. Migraines can debilitate. Nearly 30 million Americans suffer from the throbbing pain, costing employers about $13 billion a year from missed workdays and impaired work function, according to research reported in the Archives of Source: www.freep.com Woodcock Gains Support From Drugmakers for U.S. FDA's Top Job - Bloomberg Nov. 7 (Bloomberg) -- Janet Woodcock , a 22-year insider at the Food and Drug Administration, is the top choice of drugmakers who are lobbying for her to be named the agency's chief by President-elect Barack Obama , according to people associated Source: www.bloomberg.com November 6, 2008FDA Urged to Reexamine BPA - Washington Post FDA Urged to Reexamine BPA - Washington Post
The Food and Drug Administration made mistakes when it said last month that a widely used chemical found in baby bottles and a wide array of plastics was harmless and it should redo its risk assessment, an FDA advisory panel ruled today. The FDA Source: www.washingtonpost.com The FDA's risky prescription - Boston Globe FOR YEARS, pharmaceutical companies have asked Congress to pass a law protecting them from liability lawsuits for drugs that have been approved by the US Food and Drug Administration. Members of Congress, knowing only too well the fallibility of the Source: www.boston.com Juries vs. FDA on drug safety - Boston Globe WITH ORAL arguments due to be heard Monday in the Supreme Court case of Wyeth v. Levine, several members of Congress and patient advocates are raising false alarms that a decision favoring Wyeth will amount to blanket immunity for drug makers from Source: www.boston.com FDA Chief: Bisphenol-A Review Raises Important Questions - CNN Money GAITHERSBURG, Md. -(Dow Jones)- Food and Drug Administration Commissioner Andrew von Eschenbach on Friday said a highly critical review of the agency's stance on a chemical found in plastic food and drink containers raises important questions. A Source: money.cnn.com FDA Faulted for Stance on Chemical in Plastics - Forbes FRIDAY, Oct. 31 (HealthDay News) -- A U.S. Food and Drug Administration advisory panel agreed Friday that the agency had erred in August when it said that a chemical widely used in baby bottles and other plastic packaging for foods and beverages Source: www.forbes.com Consumer Group Seeks FDA Ban on Avandia - BusinessWeek THURSDAY, Oct. 30 (HealthDay News) -- The diabetes drug Avandia should be banned in the United States because it can cause death from liver failure and poses many other life-threatening risks that greatly outweigh its benefits, the advocacy group Source: www.businessweek.com Obama likely to boost FDA oversight of imports - MSNBC Obama likely to boost FDA oversight of imports - MSNBC
WASHINGTON - The Food and Drug Administration, bedeviled by a salmonella outbreak and tainted medicine from China, is likely to monitor imports and fresh produce more closely under an Obama administration. With President Bush no longer a roadblock Source: www.msnbc.msn.com FDA Approves Ranexa For Anti Anginal Use - eMaxHealth.com CV Therapeutics, Inc. (Nasdaq: CVTX) announced today that the U.S. Food and Drug Administration (FDA) has approved a new, first line indication for Ranexa (ranolazine extended-release tablets) for the treatment of chronic angina. The new labeling Source: www.emaxhealth.com Mass. drug company official gets probation - Boston Globe BOSTON— The former medical director of a Massachusetts-based pharmaceutical company has been sentenced to probation after pleading guilty to promoting off-label use of computer devices in an effort to boost sales of an AIDS drug. Dr. Norma Source: www.boston.com Under Obama, FDA would bolster food and drug safety, get new tobacco - Minneapolis Star Tribune Under Obama, FDA would bolster food and drug safety, get new tobacco - Minneapolis Star Tribune
WASHINGTON - The Food and Drug Administration, bedeviled by a salmonella outbreak and tainted medicine from China, is likely to monitor imports and fresh produce more closely under an Obama administration. With President Bush no longer a roadblock Source: www.startribune.com UPDATE 1-US FDA clears Schwarz Pharma, Pfizer bladder drug - Reuters WASHINGTON, Oct 31 (Reuters) - A new drug made by Schwarz Pharma (SRZG.DE: Quote , Profile , Research , Stock Buzz ) to treat patients with overactive bladders won approval from U.S. health officials on Friday. The drug, Toviaz, is manufactured by Source: www.reuters.com Drugmakers Lobby for Obama to Name Woodcock as FDA's Chief - Bloomberg Nov. 6 (Bloomberg) -- Drugmakers are lobbying for President-elect Barack Obama to name Janet Woodcock , a senior official of the Food and Drug Administration, as the agency's next commissioner, according to people associated with the industry Source: www.bloomberg.com Obama And The 'Drug Killer' - Forbes One of the unpleasant things I do as a consultant is recommend that pharmaceutical firms halt the production of uneconomical new medicines. I'm a drug killer. If American voters hand Barack Obama the presidency and a filibuster-proof Democratic Source: www.forbes.com CV Therapeutics gets FDA nod for Ranexa label revision, shrs up - Forbes CV Therapeutics gets FDA nod for Ranexa label revision, shrs up - Forbes
Nov 6 (Reuters) - CV Therapeutics Inc said U.S. health regulators approved its drug Ranexa as a primary treatment for chronic angina, sending its shares up more than 13 percent. Ranexa had previously been approved by the U.S. Food and Drug Source: www.forbes.com Obama expected to bolster FDA oversight of imports - Forbes The Food and Drug Administration, bedeviled by a salmonella outbreak and tainted medicine from China, is likely to monitor imports and fresh produce more closely under an Obama administration. With President Bush no longer a roadblock, health Source: www.forbes.com Dingell Seeks Support For E & C Chairmanship - CBS News (The Politico) Energy and Commerce Chairman John D. Dingell formally asked his colleagues on Thursday to support him in a fight to retain that gavel. In a letter to colleagues, Dingell lays out his three priorities for the upcoming Congress: broad Source: www.cbsnews.com Under Obama, FDA would bolster food and drug safety, get new tobacco - Minneapolis Star Tribune WASHINGTON - The Food and Drug Administration, bedeviled by a salmonella outbreak and tainted medicine from China, is likely to monitor imports and fresh produce more closely under an Obama administration. With President Bush no longer a roadblock Source: www.startribune.com Charles River plunges as drug stocks sink - Marketwatch BOSTON (MarketWatch) -- Drug stocks sank on Thursday as shares of Charles River Laboratories plunged after the company issued a lowered 2008 financial forecast. The research services provider said late Wednesday it now sees 2008 sales growing by only Source: www.marketwatch.com SFDA: Vaccine cleared in E China infant death - Xinhua News Agency BEIJING, Nov. 6 (Xinhua) -- China's drug safety authority on Thursday cleared a pneumonia and meningitis vaccine of causing the death of a 4-month-old baby last month. The baby was vaccinated against Haemophilus influenza type B, or Hib, on Oct. 19 Source: news.xinhuanet.com China stops production at drug company - Boston Globe China stops production at drug company - Boston Globe
BEIJING— China's drug safety watchdog said Thursday it has stopped all production at a company in northeastern China after an herbal injection it sold was suspected of causing the deaths of three people. The State Food and Drug Administration said Source: www.boston.com CV Therapeutics cuts loss on better Ranexa sales - CNBC PALO ALTO, Calif. - CV Therapeutics Inc. winnowed its loss by 26 percent in the third quarter, the biopharmaceutical company said Thursday, because of improved sales of its angina drug Ranexa and greater royalty and collaboration payments. CV reduced Source: www.cnbc.com HHS/FDA Grants Tentative Approval for 75th Generic Anti-Retroviral Drug as Part of President's Emergency Plan for AIDS Relief HHS/FDA Grants Tentative Approval for 75th Generic Anti-Retroviral Drug as Part of President's Emergency Plan for AIDS Relief
Marketed by Macleods Pharmaceuticals, Ltd, of Kachigam, Daman, in the Republic of India, the 75th drug is 150 milligram and 300 milligram tablets of generic lamivudine, a nucleoside analog reverse-transcriptase inhibitor (nRTI), which blocks an enzyme called reverse transcriptase, important to HIV production. HIV-infected patients who take lamivudine with other anti-HIV treatments develop less opportunistic infections. Nonna's Real Italiana Cuccine Issues an Allergy Alert on Undeclared Milk, Soy, and Wheat in Stuffed Artichokes (October 22) This product is distributed through retailers in the Greater New Orleans area including the Northshore from October 8, 2008 to October 17, 2008. The product is individually wrapped in clear plastic wrap bearing the label: "STUFFED ARTICHOKE, Net Wt. 15 oz., NONNA'S REAL ITALIANA CUCCINE". Harry and David Issues Nationwide Allergy Alert on Undeclared Pecans in Harry and David Moose Munch Confection, Milk Chocolate Gingerbread (October 22) Harry and David, of Medford, Oregon, is voluntarily recalling approximately 400 1 lb. 4 oz. boxes labeled Harry and David Moose Munch Confection, Milk Chocolate Gingerbread because the package may contain a different Moose Munch product which contains pecans not declared on the ingredient statement. People who have an allergy or severe sensitivity to pecans run the risk of serious or life-threatening allergic reaction if they consume this product. FDA Approves Toviaz, a New Drug to Treat Overactive Bladder The U.S. Food and Drug Administration has approved a new drug to help patients suffering from overactive bladder (OAB). Toviaz (fesoterodine fumarate) works by relaxing the smooth muscle tissue of the bladder, thus reducing the urinary frequency, urge to urinate, and sudden urinary incontinence (leakage of urine), that are characteristic symptoms of OAB. General Mills Issues Voluntary Class One Recall Involving One Day's Production of Progresso Hearty Tomato Soup (October 31) General Mills is voluntarily recalling a single day's production of Progresso Hearty Tomato soup because of a product labeling issue. Product produced on this date may have been mislabeled, and may contain allergens not listed on the ingredient label, specifically egg, milk, and soy. Lotte USA, Inc. Initiates Nationwide Recall of Koala's March Creme filled Cookies Lotte USA, Inc., Battle Creek, MI initiated a recall of all Koalas' March Cookies on September 29, 2008 because they were produced in China and they may be contaminated with melamine. The products are packaged in a plastic overwrap. November 5, 2008Drug Shortages: Drugs to be Discontinued; Cefotan (cefotetan injection)- updated Drug Shortages: Drugs to be Discontinued; Cefotan (cefotetan injection)- updated
See additional information in Related Information section. Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection) - updated See information in Related Information section. FDA Approves Toviaz, a New Drug to Treat Overactive Bladder The U.S. Food and Drug Administration has approved a new drug to help patients suffering from overactive bladder (OAB). Toviaz (fesoterodine fumarate) works by relaxing the smooth muscle tissue of the bladder, thus reducing the urinary frequency, urge to urinate, and sudden urinary incontinence (leakage of urine), that are characteristic symptoms of OAB. Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 See Related information section for updated Letter from Mallinckrodt Drug Shortages: Drugs to be Discontinued; SecreFlo (porcine secretin for injection, 16 mcg/vial) See Related information section HHS/FDA Grants Tentative Approval for 75th Generic Anti-Retroviral Drug as Part of President's Emergency Plan for AIDS Relief Marketed by Macleods Pharmaceuticals, Ltd, of Kachigam, Daman, in the Republic of India, the 75th drug is 150 milligram and 300 milligram tablets of generic lamivudine, a nucleoside analog reverse-transcriptase inhibitor (nRTI), which blocks an enzyme called reverse transcriptase, important to HIV production. HIV-infected patients who take lamivudine with other anti-HIV treatments develop less opportunistic infections. Recalls and Safety Alerts: Importance of Influenza Vaccination for Health Care Personnel As the flu season approaches, FDA is urging healthcare facilities to ensure that influenza vaccination programs are available for their personnel. Vaccinating healthcare workers will decrease the likelihood that they will contract influenza, and als... Drug Shortages: Drugs to be Discontinued; Foscavir (foscarnet sodium) injection See Web site for additional information Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 See Web site for additional information on this current drug shortage Caraco Pharmaceutical Laboratories, Ltd. to Market Generic Sinemet(R - MSN MoneyCentral Caraco Pharmaceutical Laboratories, Ltd. to Market Generic Sinemet(R - MSN MoneyCentral
DETROIT , Nov. 5 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd. CPD announced today, that it has launched Carbidopa and Levodopa tablets on behalf of Sun Pharmaceutical Industries Ltd. (Sun Pharma). Sun Pharma recently received Source: news.moneycentral.msn.com AspenBio Pharma to Present at the Lazard Capital Markets 5th Annual - MSN MoneyCentral AspenBio Pharma, Inc. (NASDAQ: APPY), an emerging bio-pharmaceutical company dedicated to the development of diagnostics and novel drugs for humans and animals, has been invited to present at the Fifth Annual Lazard Healthcare Conference to be held Source: news.moneycentral.msn.com FDA Objected to Regulation Moves, Rep. Waxman Says - Wall Street Journal WASHINGTON -- The Food and Drug Administration has enacted a slew of rules to weaken the ability of states to sue drug companies despite objections from top agency officials, according to internal FDA documents released Wednesday by Rep. Henry Waxman Source: online.wsj.com FDA ignored evidence when calling BPA safe - USA Today The Food and Drug Administration ignored evidence when concluding that a chemical in plastic baby bottles is safe, according an expert panel asked to review the agency's handling of the controversial substance. Studies that the FDA ignored show that Source: www.usatoday.com Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection) Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection)
See Web site for additional information. Drug Shortages: Resolved Drug Shortages; Zanosar (Streptozocin) 1gm/vial Injection See Web site for additional information Russell Stover Candies, Inc. Issues Hazelnut Allergy Alert for the 2 7/8 Oz Size Of Private Reserve Assorted Chocolates (October 9) Russell Stover Candies, Inc. Issues Hazelnut Allergy Alert for the 2 7/8 Oz Size Of Private Reserve Assorted Chocolates (October 9)
The recalled product was distributed in the following states and cities: Texas, California, Louisiana, North Carolina, South Carolina, Virginia, Tennessee; Southaven, Mississippi; Billings, Montana; Sparks, Nevada; and Madison Heights, Michigan. An investigation determined 29 boxes of this candy may have been purchased by consumers, and up to another 188 boxes may have reached retail store locations. All the retail stores have been contacted to have the suspected product removed from the shelves. Over The Counter Cough and Cold Medications Product labels being modified to state "do not use" in children under 4 years of age. FDA's conclusion that chemical is safe is flawed - International Herald Tribune FDA's conclusion that chemical is safe is flawed - International Herald Tribune
WASHINGTON : The Food and Drug Administration's assurances that a controversial chemical is safe for use in food containers are badly flawed, an independent panel of scientific advisers concluded in a report released Tuesday. The chemical, known as Source: www.iht.com BPA Ruling Flawed, Panel Says: FDA Ignored Scientific Evidence of - Washington Post The Food and Drug Administration ignored scientific evidence and used flawed methods when it determined that a chemical widely used in baby bottles and in the lining of cans is not harmful, a scientific advisory panel has found. In a highly critical Source: www.washingtonpost.com FDA slams Bayer for claims on aspirin benefits - San Francisco Gate Wednesday, October 29, 2008 The Food and Drug Administration scolded the company in two warning letters for never submitting proof that its pills - Bayer Women's Low Dose Aspirin + Calcium and Bayer Aspirin with Health Advantage - are effective in Source: www.sfgate.com November 4, 2008Drug Shortages: Drugs to be Discontinued; SecreFlo (porcine secretin for injection, 16 mcg/vial) Drug Shortages: Drugs to be Discontinued; SecreFlo (porcine secretin for injection, 16 mcg/vial)
See Web site for additional information Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 See Web site for additional information on this current drug shortage Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 (updated) Updated letter on this current drug shortage Drug Shortages: Drugs to be Discontinued; SecreFlo (porcine secretin for injection, 16 mcg/vial) See Related information section Recalls and Safety Alerts: Importance of Influenza Vaccination for Health Care Personnel As the flu season approaches, FDA is urging healthcare facilities to ensure that influenza vaccination programs are available for their personnel. Vaccinating healthcare workers will decrease the likelihood that they will contract influenza, and als... Sanvar(R) (Debio 8609) for esophageal variceal bleeding - Debiopharm - CNW Group Sanvar(R) (Debio 8609) for esophageal variceal bleeding - Debiopharm - CNW Group
Attention News Editors: Sanvar(R) (Debio 8609) for esophageal variceal bleeding - Debiopharm submits response to the FDA LAUSANNE, Switzerland, Nov. 4 /CNW Telbec/ - Debiopharm Group (Debiopharm), a global biopharmaceutical development specialist Source: www.newswire.ca Drugmakers urge high court to bar some suits by patients - Philadelphia Inquirer Drugmakers urge high court to bar some suits by patients - Philadelphia Inquirer
U.S. Supreme Court justices suggested yesterday that they might give drugmakers a partial victory in a fight over lawsuits by patients injured by medicines approved by the Food and Drug Administration. Hearing a Wyeth appeal, several justices Source: www.philly.com UPDATE:Sun Pharma:FDA Letter To Caraco Won't Affect FY Sales - Wall Street Journal BANGALORE (Dow Jones)--Drug maker Sun Pharmaceutical Industries Ltd. (524715.BY) said Tuesday a warning letter sent by the U.S. Food and Drug Administration to its U.S. unit, Caraco Pharmaceutical Laboratories Inc. (CPD), won't hurt its sales in the Source: online.wsj.com Court weighs amputee's case against drugmaker - San Francisco Gate Tuesday, November 4, 2008 Several justices indicated that if the U.S. Food and Drug Administration had clear information about the risks of Wyeth Pharmaceuticals' anti-nausea drug Phenergan, and approved its warning label anyway, then Wyeth probably Source: www.sfgate.com HemaQuest Pharmaceuticals Receives Orphan Drug Designations for - Market Wire BOSTON, MA--(Marketwire - November 4, 2008) - HemaQuest Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has awarded the company orphan drug designations for sickle cell anemia and beta thalassemia for HQK-1001, which Source: www.marketwire.com Justices ponder patient lawsuits against drug makers - New London Day Washington - On the day before the nation elects a new president, the Supreme Court debated an important legal legacy of the outgoing Bush administration. Two years ago, the administration said drug makers should be shielded from being sued by Source: www.theday.com US FDA suspends drug approvals from Sun's US subsidiary Caraco - Business Standard The United States Food and Drug Administration (USFDA) has on October 31 issued a warning letter to Caraco Pharmaceutical Laboratories, the US subsidiary of Sun Pharmaceuticals Ltd, withholding all future marketing approvals for medicines Source: www.business-standard.com Acorda Therapeutics Reports Third Quarter 2008 Financial Results - MSN MoneyCentral Acorda Therapeutics, Inc. ACOR today announced its financial results for the third quarter of 2008. “ We made significant progress this quarter in preparing a New Drug Application for Fampridine-SR, which we expect to submit electronically to the U Source: news.moneycentral.msn.com Bottled Water Everywhere: Keeping it Safe Bottled Water Everywhere: Keeping it Safe
Americans drink billions of gallons of bottled water each year. Find out about FDA's role in ensuring that bottled water products are safe. Drug Shortages: Drugs to be Discontinued; Nimotop (nimodipine) capsules See Web site for additional information Irradiation: A Safe Measure for Safer Iceberg Lettuce and Spinach In the fight against foodborne illness, FDA is permitting fresh iceberg lettuce and fresh spinach to be irradiated at safe doses. Drug Shortages: Resolved Drug Shortages; Proglycem (diazoxide) oral suspension See Web site for additional information November 3, 2008UPDATE 1-FDA warns Bayer over aspirins with supplements - Reuters UPDATE 1-FDA warns Bayer over aspirins with supplements - Reuters
WASHINGTON, Oct 28 (Reuters) - U.S. health regulators have warned Bayer (BAYG.DE: Quote , Profile , Research , Stock Buzz ) for selling two over-the-counter aspirin medications that contain dietary supplements without getting approval first Source: www.reuters.com U.S. top court weighs drugmaker liability for harm - Reuters UK WASHINGTON (Reuters) - Pharmaceutical companies should not be liable for harm from medicines that carry warnings approved by federal regulators, lawyers for drugmaker Wyeth and the Bush administration told the U.S. Supreme Court on Monday. The court Source: uk.reuters.com Juries vs. FDA on drug safety - Boston Globe WITH ORAL arguments due to be heard Monday in the Supreme Court case of Wyeth v. Levine, several members of Congress and patient advocates are raising false alarms that a decision favoring Wyeth will amount to blanket immunity for drug makers from Source: www.boston.com FDA warns Bayer on unproven claims - CNN Money WASHINGTON (AP) -- Aspirin medicines from Bayer designed to promote healthy hearts and stronger bones are being marketed illegally with unproven health claims, federal regulators said Tuesday. The Food and Drug Administration scolded the company in Source: money.cnn.com Panel: FDA’s conclusion on BPA safety is flawed - MSNBC WASHINGTON - An independent panel of science advisers is taking issue with the FDA’s assessment that a controversial chemical is safe. In a report to the agency, the panel concluded: “The margins of safety identified by FDA as ’adequate’ are Source: www.msnbc.msn.com FDA warns Bayer over aspirins with supplements - Forbes WASHINGTON (Reuters) - U.S. health regulators have warned Bayer (nyse: BAY - news - people ) for selling two over-the-counter aspirin medications that contain dietary supplements without getting approval first, according to documents released Tuesday Source: www.forbes.com Supreme Court weighs lawsuits against drug makers - Los Angeles Times Reporting from Washington -- On the day before the nation elects a new president, the Supreme Court debated an important legal legacy of the outgoing Bush administration. Two years ago, the administration said drug makers should be shielded from Source: www.latimes.com A Single Test to Detect Many Winter Ailments - Wall Street Journal A new cold and flu test can precisely diagnose a dozen winter ailments and reduce unneeded use of antibiotics, says the company that sells it. Physicians say the test is accurate and the most comprehensive available, but some say its long processing Source: online.wsj.com Legal Side Effects - Wall Street Journal Diana Levine's story is gut-wrenching. It's also the sort of case that makes bad law, which is why Monday's Supreme Court oral argument in Wyeth v. Levine is important for consumers and drug development in America. A professional guitarist who Source: online.wsj.com 2nd UPDATE: Supreme Court Appears Conflicted In Wyeth Case - CNN Money WASHINGTON -(Dow Jones)- The Supreme Court sharply questioned pharmaceutical giant Wyeth (WYE) and a plaintiff over arguments about whether Food and Drug Administration regulation of drug labeling prevents consumers from suing, in a case that could Source: money.cnn.com Safety Concerns and Labeling Changes for Psoriasis Drug Raptiva Safety Concerns and Labeling Changes for Psoriasis Drug Raptiva
FDA has received reports of serious infections leading to hospitalizations and deaths in people who use Raptiva. Raptiva (efalizumab) Risk of life-threatening infections associated with Raptiva use. Outsmarting Poison Ivy and Other Poisonous Plants Poison ivy and other poisonous plants are a hazard all year round. Here are tips for preventing and treating the itchy rash and blisters. Keeping Watch Over Direct-to-Consumer Ads FDA regulates direct-to-consumer advertising for prescription drugs, working to ensure that ads are truthful, balanced, and accurate. Mexican Vanilla With Coumarin: No Bargain Beware of Mexican vanilla that contains coumarin, a toxic substance banned in the United States. Recalls and Melamine Contamination FDA has increased inspections and product testing in response to the melamine contamination problem that originated in Chinese dairy products. Draft Guidance on Genetically Engineered Animals The technology of genetic engineering offers many benefits for health, agriculture, and the environment. FDA tells how it is regulating genetically engineered animals. Vibe Technologies Vibrational Integrated Bio-photonic Energizer Machine Multi-Frequency Field Generator Class I recall because of unsupported claims. Court Considers If Amputee Can Sue Drug Company - The Ledger Court Considers If Amputee Can Sue Drug Company - The Ledger
WASHINGTON | A Vermont musician who lost her arm because of a botched drug injection is squaring off against a drug maker and the Bush administration in one of the most closely watched business cases of the Supreme Court's term. At issue is whether Source: www.theledger.com Supreme Court considers the reach of drug warning labels - Los Angeles Times Supreme Court considers the reach of drug warning labels - Los Angeles Times
Reporting from Washington -- The Supreme Court justices sounded closely split today on whether to shield drug makers from being sued if they fail to warn patients and doctors of all the risks of a prescription drug. The justices heard the case of Source: www.latimes.com UPDATE: Supreme Court Appears Conflicted In Wyeth Case - CNN Money WASHINGTON -(Dow Jones)- The Supreme Court sharply questioned pharmaceutical giant Wyeth (WYE) and a plaintiff over arguments about whether Food and Drug Administration regulation of drug labeling prevents consumers from suing, in a case that could Source: money.cnn.com Court Considers If Amputee Can Sue Drug Company - The Ledger WASHINGTON | A Vermont musician who lost her arm because of a botched drug injection is squaring off against a drug maker and the Bush administration in one of the most closely watched business cases of the Supreme Court's term. At issue is whether Source: www.theledger.com Court hears amputee's case on drug suit limits - Houston Chronicle WASHINGTON — The Bush administration and a drug maker urged the Supreme Court today to throw out a multimillion dollar verdict to a Vermont musician who lost her arm because of a botched injection to relieve nausea. The case is being watched Source: www.chron.com Sector Snap: Vertex get boost from hep C drug - MSN MoneyCentral InterMune Inc ( ITMN ) Stock Quote , Chart , News , Add to Watchlist NEW YORK (AP) - Shares of Vertex Pharmaceuticals Inc. gained ground Monday as analysts looked to the company's developing hepatitis C drug as a potential market leader after viewing Source: news.moneycentral.msn.com Court Hears Amputee's Case on Limits of Drug Suits - ABC News Justices begin to hear cases on drug labels and "fleeting expletives." The Bush administration and a drug maker urged the Supreme Court on Monday to throw out a multimillion dollar verdict to a Vermont musician who lost her arm because of a botched Source: www.abcnews.go.com Barr receives FDA OK for generic Pfizer drug - MSN MoneyCentral MONTVALE, N.J. (AP) - Generic drug developer Barr Pharmaceuticals Inc. said Monday its Pliva-Lachema subsidiary received Food and Drug Administration approval for a generic version of Pfizer Inc.'s colon-cancer drug Camptosar. New York-based Pfizer Source: moneycentral.msn.com US court weighs amputee's case in drug suit - International Herald Tribune WASHINGTON : The U.S. Supreme Court appeared likely Monday to decide an amputee's lawsuit against a drug maker based on how much federal regulators knew about an anti-nausea drug's risks in the event of a botched injection. Several justices indicated Source: www.iht.com Akorn gets approval for heart rhythm disorder drug - Boston Globe LAKE FOREST, Ill.— Drug developer Akorn Inc. said Monday the Food and Drug Administration approved its generic version of a heart rhythm disorder treatment. The company said it gained approval for the adenosine injection. There are other generic Source: www.boston.com Supreme Court takes up drug warning labels - Christian Science Monitor Supreme Court takes up drug warning labels - Christian Science Monitor
Reporter Warren Richey discusses a Supreme Court case testing whether federal law and regulations preempt state-mandated consumer protections regarding medical drugs. WASHINGTON - The US Supreme Court is examining whether medical patients can sue a Source: www.csmonitor.com FDA Gives Thumbs Up To Overactive Bladder Drug, Toviaz - dbtechno.com Washington (dbTechno) - The U.S. Food and Drug Administration (FDA) has given the thumbs up in approving the new drug Toviaz, which treats overactive bladder (OAB) in adults. The drug is manufactured by Schwarz Pharma in Germany, and is distributed Source: www.dbtechno.com Court weighs amputee's case, limits on drug suits - Forbes A Vermont musician who lost her arm because of a botched drug injection is squaring off against a drug maker and the Bush administration in one of the most closely watched business cases of the Supreme Court's term. At issue is whether the federal Source: www.forbes.com Panel Slashes FDA over Bisphenol Safety - Eflux Media A panel of environmental health, toxicology and statistics experts from three major universities, the Environmental Protection Agency and the Centers for Disease Control and Prevention concluded on Wednesday that the Food and Drug Administration Source: www.efluxmedia.com Aurora Imaging Technology Receives FDA Clearance for Spectroscopy - Genetic Engineering News Aurora Imaging Technology Inc. is proud to announce that the Aurora(R) 1.5Tesla Dedicated Breast MRI System has received 501(k) clearance from the U.S. Food and Drug Administration (FDA) for AuroraSPECTROSCOPY(TM), the company's breast magnetic Source: www.genengnews.com Court weights amputee's case, limits on drug suits - Boston Globe Court weights amputee's case, limits on drug suits - Boston Globe
WASHINGTON— A Vermont musician who lost her arm because of a botched drug injection is squaring off against a drug maker and the Bush administration in one of the most closely watched business cases of the Supreme Court's term. At issue is whether Source: www.boston.com November 2, 2008Outsmarting Poison Ivy and Other Poisonous Plants Outsmarting Poison Ivy and Other Poisonous Plants
Poison ivy and other poisonous plants are a hazard all year round. Here are tips for preventing and treating the itchy rash and blisters. FDA Warns Bayer About Two Unapproved Aspirin Products FDA has sent warning letters to Bayer HealthCare regarding two over-the-counter products that combine aspirin with a dietary supplement into a single pill. Addressing Questions About Gardasil FDA addresses the safety of Gardasil, a vaccine that prevents infection with types of human papillomavirus (HPV) Preventing Medical Errors: Tragic Events with Concentrated Opiate Oral Solutions An alert from the Institute for Safe Medication Practices warns about potentially fatal errors that can occur with concentrated oral opiate solutions. ISMP cites a recent case involving an 18 year old who was prescribed oxycodone oral solution to ... Recalls and Safety Alerts: Serious Muscle Injury with Simvastatin/Amiodarone Combination FDA is reminding healthcare professionals that patients who take amiodarone along with drugs that contain simvastatin have an increased risk of rhabdomyolysis, a type of muscle injury that can lead to kidney failure and death. Amiodarone is an antia... Improper Use of Decorative Contacts May Haunt You Halloween is a good time to remind people that improper use of non-prescription decorative contact lenses may harm your vision Barry Callebaut USA LLC Issues Allergen Alert on Undeclared Milk Protein in Kroger Value Semi Sweet Chocolate Chips (October 10) Barry Callebaut USA LLC is conducting a voluntary recall on its product sold by Kroger Stores under the brand "Kroger Value Semi Sweet Chocolate Chips", 12 oz., UPC Code is 11110–86603 and "sell by" date May 30, 2010, as the product may contain undeclared milk protein. The "sell by" date is found printed in black on the end of the bag. People with allergies or severe sensitivity to milk protein may be at risk of serious or life-threatening allergic reaction if they consume this product. The Future of the FDA in the Next Administration - ABC News The Future of the FDA in the Next Administration - ABC News
It is now eight days before a historic election, but no matter which candidate becomes the next president of the United States, he will face a long list of challenges. While the economy and foreign policy take center stage in the presidential Source: abcnews.go.com State collects $2 million in drug suit - Boston Globe MONTPELIER, Vt.— Attorney General William Sorrell says Vermont will collect $2 million from drug company Pfizer to settle a lawsuit over the company's marketing practices. Vermont and 32 other states have been settling lawsuits against the company Source: www.boston.com In Drug Case, Justices to Weigh Right to Sue - Wall Street Journal For nearly a century, Americans have been able to sue drug companies for deaths or injuries caused by medicines. Now the pharmaceutical industry and other big businesses are hoping the Supreme Court will sharply curb that right. Stephen Breyer In a Source: online.wsj.com Almost half of women have sexual problems in U.S. - Xinhua News Agency BEIJING, Nov. 3 (Xinhuanet) -- A new research shows that 40 percent of women report sexual problems in the United States, but only 12 percent are distressed about it, according to media reports Monday. The research was led by Dr. Jan Shifren, an Source: news.xinhuanet.com Nonna's Real Italiana Cuccine Issues an Allergy Alert on Undeclared Milk, Soy, and Wheat in Stuffed Artichokes (October 22) Nonna's Real Italiana Cuccine Issues an Allergy Alert on Undeclared Milk, Soy, and Wheat in Stuffed Artichokes (October 22)
This product is distributed through retailers in the Greater New Orleans area including the Northshore from October 8, 2008 to October 17, 2008. The product is individually wrapped in clear plastic wrap bearing the label: "STUFFED ARTICHOKE, Net Wt. 15 oz., NONNA'S REAL ITALIANA CUCCINE". Lotte USA, Inc. Initiates Nationwide Recall of Koala's March Creme filled Cookies Lotte USA, Inc., Battle Creek, MI initiated a recall of all Koalas' March Cookies on September 29, 2008 because they were produced in China and they may be contaminated with melamine. The products are packaged in a plastic overwrap. ETHEX Corporation Voluntarily Recalls Three Lots of Dextroamphetamine Sulfate 5mg Tablets Due to the Potential for Oversized Tablets (October 15) ETHEX Corporation announced today that it has voluntarily recalled three specific lots (77946, 81141 and 81142) of Dextroamphetamine Sulfate 5 mg tablets, as a precaution, due to the possible presence of oversized tablets. Oversized tablets may contain as much as about twice the labeled amount of the active ingredient. The recalled lots were distributed by ETHEX Corporation under an "ETHEX" label between January 2007 and May 2008. The 5 mg product is an orange round tablet debossed with "ETHEX" and "311" on one side. Thoratec Corporation Issues Worldwide Medical Device Correction of HeartMate II Left Ventricular Assist System (October 24) Thoratec Corporation is initiating a worldwide medical device correction of all serial numbers of the HeartMate II Left Ventricular Assist Systems (HM II LVAS) having Catalogue No. 1355 or 102139, which have been distributed since the beginning of clinical studies in November 2003. Over time, wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood pump with the System Controller may result in damage that could interrupt pump function, require reoperation to replace the pump and potentially result in serious injury or death. Barry Callebaut USA LLC Issues Allergen Alert on Undeclared Milk Protein in Kroger Value Semi Sweet Chocolate Chips (October 10) Barry Callebaut USA LLC is conducting a voluntary recall on its product sold by Kroger Stores under the brand "Kroger Value Semi Sweet Chocolate Chips", 12 oz., UPC Code is 11110–86603 and "sell by" date May 30, 2010, as the product may contain undeclared milk protein. The "sell by" date is found printed in black on the end of the bag. People with allergies or severe sensitivity to milk protein may be at risk of serious or life-threatening allergic reaction if they consume this product. HUA XIA Food Trade USA, Inc. Recalls YILI Brand Sour Milk Drink and YILI Brand Pure Milk Drink, Because of Possible Health Risk (October 10) HUA XIA Food Trade USA, Inc. of Flushing, NY, is recalling YILI Brand Sour Milk Drink packaged in 250ml flexible paperboard boxes (all codes and all lots are affected) and YILI Brand Pure Milk Drink packaged in 250ml flexible paperboard boxes (all codes and all lots are affected) because it may be contaminated with melamine. Consumer Alert: Possible Botulism Contamination in Frozen Salted Croaker (October 6) Consumer Alert: Possible Botulism Contamination in Frozen Salted Croaker (October 6)
New York State Agriculture Commissioner alerted consumers not to eat Frozen Salted Croaker distributed by YS Trading Corp, Long Island City, New York because the product was uneviscerated. The Frozen Salted Croaker was sold in Hicksville, New York, Flushing, New York, and New Jersey in un-coded, unlabeled plastic bags. Cricket community hails Kumble the fighter - Hindustan Times Cricket community hails Kumble the fighter - Hindustan Times
The Indian and international cricket community on Sunday paid glowing tributes to Anil Kumble, calling him a great competitor, role model and a true fighter and his decision to retire as an end of an era. Chief selector Krishnamachari Srikkanth Source: www.hindustantimes.com Schwarz Pharma, Pfizer Toviaz Gets FDA Clearance for Overactive - Eflux Media US regulators on Friday approved Toviaz (fesoterodine fumarate) for patients suffering from overactive bladder. The drug is made by Germany’s Schwarz Pharma and distributed in the US by Pfizer Inc of New York. “Patients who suffer from overactive Source: www.efluxmedia.com EDITORIAL: Conflict taints FDA safety review - New Haven Register No comments posted. Concerns mount about chemical used in plastic for baby and drinking bottles. The U.S. Food and Drug Administration said in August that bisphenol A, or BPA, a chemical used in hard plastics such as water bottles and coatings of Source: www.nhregister.com UPDATE 1-Barr gets FDA nod for oral contraceptive - Reuters Oct 27 (Reuters) - Barr Pharmaceuticals Inc (BRL.N: Quote , Profile , Research , Stock Buzz ) said the U.S. regulators approved an oral contraceptive made by its unit Duramed Pharmaceuticals Inc. Barr, which agreed to be bought by Israel-based Teva Source: www.reuters.com UPDATE 1-Barr gets FDA nod for oral contraceptive - Reuters UPDATE 1-Barr gets FDA nod for oral contraceptive - Reuters
Oct 27 (Reuters) - Barr Pharmaceuticals Inc (BRL.N: Quote , Profile , Research , Stock Buzz ) said the U.S. regulators approved an oral contraceptive made by its unit Duramed Pharmaceuticals Inc. Barr, which agreed to be bought by Israel-based Teva Source: www.reuters.com Supreme Court weighs drug lawsuits - San Francisco Gate Sunday, November 2, 2008 Seuferer's claim is one of many thousands of suspended cases across the country that hang on the decision of the U.S. Supreme Court in a pivotal case to be argued Monday. The question before the high court is whether patients Source: www.sfgate.com Chemical Found In Baby Bottles May Not Be Safe, Panel Rules - All Headline News (AHN) - The Food and Drug Administration's determination that a widely-used chemical found in baby bottles is safe contained mistakes and should be redone, an FDA panel unanimously ruled. The chemical, bisphenol-A, or BPA, is also found in many other Source: www.allheadlinenews.com The Future of the FDA in the Next Administration - ABC News It is now eight days before a historic election, but no matter which candidate becomes the next president of the United States, he will face a long list of challenges. While the economy and foreign policy take center stage in the presidential Source: abcnews.go.com Is BPA safe? Health officials leave consumers confused - HometownAnnapolis.com BPA - a chemical used in food containers - is so widespread most people have traces of it in their bodies. But health officials can't decide if that's a problem, or something we all can live with. Bisphenol A is useful for hardening plastics to make Source: www.hometownannapolis.com FDA Warns of Dangers of Mexican Vanilla - Atlanta Journal Constitution FDA Warns of Dangers of Mexican Vanilla - Atlanta Journal Constitution
FRIDAY, Oct. 31 (HealthDay News) -- So-called Mexican "vanilla" is often made with a toxic substance called coumarin and shouldn't be bought by consumers, the U.S. Food and Drug Administration warned this week. Coumarin is related to warfarin, which Source: www.ajc.com New drug may treat gout, researchers say - Boston Globe WASHINGTON - A new drug that imitates a blood-clearing enzyme missing in humans appears to treat serious cases of gout safely, US researchers reported yesterday. The Savient Pharmaceuticals drug, called pegloticase, helped remove uric acid, which Source: www.boston.com When can a drug consumer sue? - Philadelphia Inquirer Diana Levine went to the hospital eight years ago for the same reason she had gone many times before, a migraine headache. The treatment was the same, too - Demerol for pain and Phenergan, a Wyeth drug, for nausea. Over the next few weeks, her lower Source: www.philly.com Got a sick kid? Home remedies may be better than OTC cold medicines - Seattle Times Q: I have read that cold medicines for children continue to be sold even though they have not been thoroughly tested. Sadly, some businesses are quick to put out OTC medications just to turn a profit (and a rather large one at that). After all, if it Source: seattletimes.nwsource.com The Future of the FDA in the Next Administration - ABC News The Future of the FDA in the Next Administration - ABC News
It is now eight days before a historic election, but no matter which candidate becomes the next president of the United States, he will face a long list of challenges. While the economy and foreign policy take center stage in the presidential Source: abcnews.go.com FDA accepts call for more research on BPA hazards - Minneapolis Star Tribune WASHINGTON - The Food and Drug Administration made mistakes when determining that a widely used chemical found in baby bottles and other plastics was harmless and the agency should redo its risk assessment, an FDA advisory panel ruled Friday. But the Source: www.startribune.com Drugs Delayed in U.S. as Regulators Struggle With New Duties - Bloomberg Oct. 27 (Bloomberg) -- The Food and Drug Administration is missing target dates to act on new drug applications because the agency doesn't have enough staff to handle them after getting new duties from Congress a year ago, an FDA official said. The U Source: www.bloomberg.com UPDATE 1-Barr gets FDA nod for oral contraceptive - Reuters Oct 27 (Reuters) - Barr Pharmaceuticals Inc (BRL.N: Quote , Profile , Research , Stock Buzz ) said the U.S. regulators approved an oral contraceptive made by its unit Duramed Pharmaceuticals Inc. Barr, which agreed to be bought by Israel-based Teva Source: www.reuters.com Pfizer's TOVIAZ(TM) (fesoterodine fumarate) Receives FDA Approval for - MSN MoneyCentral Pfizer Inc said today that the U.S. Food and Drug Administration (FDA) approved TOVIAZ ™ (fesoterodine fumarate) extended release tablets for the treatment of overactive bladder (OAB) symptoms. New once-daily TOVIAZ can significantly reduce the Source: news.moneycentral.msn.com FDA Approves Duramed's LoSEASONIQUE(R) Oral Contraceptive - MSN MoneyCentral Duramed to Launch First Lower-Dose, Extended-Cycle Oral Contraceptive for the Prevention of Pregnancy MONTVALE, N.J. , Oct. 27 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. BRL today announced that the U.S. Food and Drug Administration (FDA Source: news.moneycentral.msn.com Consumer Group Seeks FDA Ban of Glaxo's Avandia - Wall Street Journal WASHINGTON -- The consumer group Public Citizen asked the U.S. Food and Drug Administration Thursday to ban GlaxoSmithKline PLC's troubled diabetes drug Avandia over safety concerns. The move follows updated practice guidelines released last week by Source: online.wsj.com |
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