October 25, 2008Clearing the way for low-cost biogenerics - Boston Globe Clearing the way for low-cost biogenerics - Boston Globe
NOW THAT the United States is in hock to China, it needs to save money. One answer is cutting healthcare costs, with the lowest hanging fruit being biologics. Biologics are protein-based, rather than chemical-based, medicines. They are wonder drugs Source: www.boston.com Sight loss drug to be licensed as cosmetic - The Independent It started out as a medicine, a prosaic treatment for glaucoma. Now it is being used for its cosmetic effects, promising to turn women into doe-eyed beauties within days. The drug firm Allergan – the £1.5bn global company behind Botox – believes Source: www.independent.co.uk Rx for Ailing Investors? - Wall Street Journal The health-care industry is in the midst of an innovation renaissance, even as big pharmaceutical companies lose patent protection on their most lucrative drugs. With huge challenges looming for the industry, companies developing new ways to improve Source: online.wsj.com Takeda says FDA delays decision on ulcer drug - Forbes TOKYO, Oct 20 (Reuters) - Takeda Pharmaceutical Co, Japan's largest drugmaker, said on Monday U.S. regulators have put back the date for a response to Takeda's application for approval of a key ulcer drug candidate due to a delay in the examination Source: www.forbes.com UPDATE 1-Forest, Cypress fibromyalgia drug delayed at FDA - Reuters BOSTON, Oct. 20 (Reuters) - Forest Laboratories Inc (FRX.N: Quote , Profile , Research , Stock Buzz ) and Cypress Bioscience Inc (CYPB.O: Quote , Profile , Research , Stock Buzz ) said on Monday the U.S. Food and Drug Administration was not able to Source: www.reuters.com UPDATE 1-Takeda says U.S. delays ulcer drug decision - Reuters TOKYO, Oct 20 (Reuters) - Japan's Takeda Pharmaceutical Co (4502.T: Quote , Profile , Research , Stock Buzz ) said U.S. regulators have pushed back the possible approval of a key drug candidate, the latest in a string of delays in the world's largest Source: www.reuters.com NAFDAC Blacklists 22 Firms over Fake Drugs - This Day Online Fifteen Indian and seven Nigerian pharmaceutical companies indicted for manufacturing fake drugs, documents forgery and other unethical practices have been blacklisted by National Agency for Food and Drug Administration and Control (NAFDAC Source: www.thisdayonline.com Hunting medicine's holy grail - News.com.au THE world stands on the brink of a medical revolution. Within months, the first human tests using embryonic stem cell therapy will be carried out in Australia and the US. Embryonic stem cell research is about to fulfil its promise and at the heart of Source: www.news.com.au FDA wants more data on AMAG anemia drug - Boston Globe Biotechnology company AMAG Pharmaceuticals Inc. of Cambridge said today that the Food and Drug Administration wants more information on a prospective anemia drug before considering it for approval. In December, AMAG asked the FDA to approve Source: www.boston.com Pozen falls on potential drug candidate delays - Forbes Shares of drug developer Pozen Inc. declined in Monday trading, as analysts cut their ratings on the stock and wondered if regulators will hold off on approving two of the company's drug candidates. Citi Investment Research analyst Lucy Lu downgraded Source: www.forbes.com Keeping Watch Over Direct-to-Consumer Ads 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. Using Over-the-Counter Cough and Cold Products in Children FDA supports the voluntary actions of drug manufacturers to better inform consumers about the safe and effective use of over-the-counter cough and cold medicines in children. Recalls and Safety Alerts: Avoiding Cardiotoxicity with Mitoxantrone FDA is reemphasizing the importance of monitoring cardiac function in patients treated with mitozantrone, sold as Novantrone and also as a generic. Mitozantrone is used to treat certain patients with prostate cancer, leukemia and multiple sclerosis ... FDA Detects Melamine Contamination in Flavored Drink The U.S. Food and Drug Administration (FDA) has increased inspections and product testing efforts in response to the melamine contamination problem which originated in Chinese dairy products. As a result of the FDA's on-going testing program, the agency has detected melamine contamination in Blue Cat Flavor Drinks. The distributor of the product, Tristar Food Wholesale Co. Inc., initiated a recall of several flavors of Blue Cat Flavor Drink, based on the FDA’s findings. The FDA advises the public not to consume this product and recommends that retailers and food service operators remove the product from sale or service. 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 Is marijuana good medicine? - Detroit Free Press Is marijuana good medicine? - Detroit Free Press
For many voters, the decision to back or reject a proposal to give people with severe and terminal illnesses legal access to marijuana will come down to their thoughts on compassion for sick and dying people versus those on preventing drug abuse. It Source: www.freep.com FDA wants more data on AMAG anemia drug - Boston Globe Biotechnology company AMAG Pharmaceuticals Inc. of Cambridge said today that the Food and Drug Administration wants more information on a prospective anemia drug before considering it for approval. In December, AMAG asked the FDA to approve Source: www.boston.com Hunting medicine's holy grail - News.com.au THE world stands on the brink of a medical revolution. Within months, the first human tests using embryonic stem cell therapy will be carried out in Australia and the US. Embryonic stem cell research is about to fulfil its promise and at the heart of Source: www.news.com.au Takeda says FDA delays decision on ulcer drug - Reuters TOKYO, Oct 20 (Reuters) - Takeda Pharmaceutical Co (4502.T: Quote , Profile , Research , Stock Buzz ), Japan's largest drugmaker, said on Monday U.S. regulators have put back the date for a response to Takeda's application for approval of a key ulcer Source: www.reuters.com Sleeping pill Lunesta, used incorrectly, can be deadly - Newsday Isiah Thomas ' house Friday is unique because it can be prescribed for a significantly longer period of time than other similar medications, a sleep disorder expert told Newsday Friday. According to Dr. Jorge Mallea, medical director of the sleep Source: www.newsday.com Vermont gets $2 million in lawsuit - Times-Argus Pfizer will pay Vermont $2 million to settle a lawsuit over its marketing practices, according to Attorney General William Sorrell. Vermont is one of 33 states settling lawsuits against the pharmaceutical company for a total of $60 million, according Source: www.timesargus.com ROTATEQ(R) Substantially Reduced Rotavirus-related Hospitalizations - MSN MoneyCentral ROTATEQ ® (rotavirus vaccine, live, oral, pentavalent) reduced rotavirus-related hospitalizations and emergency room (ER) visits combined by 100 percent during the 2007 and 2008 rotavirus seasons (January through May of each year) in an Source: news.moneycentral.msn.com FDA opening China office to inspect imports - Atlanta Journal Constitution WASHINGTON — The Food and Drug Administration will establish its first office in China before the end of the year as part of a broader plan to assure the safety of imports from the developing world. FDA Commissioner Andrew von Eschenbach on Source: www.ajc.com Daiichi Sankyo, Eli Lilly say new blood thinner still on track for FDA - Minneapolis Star Tribune Secret, double life of a Walgreens druggist A nasty bug, an effective (but yucky) cure Running for my life: 1 woman's race against time Strong growth in Medicaid anticipated Hawaii ending universal child health care TOKYO - Japanese drug maker Source: www.startribune.com 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. 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. 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. Is marijuana good medicine? - Detroit Free Press Is marijuana good medicine? - Detroit Free Press
For many voters, the decision to back or reject a proposal to give people with severe and terminal illnesses legal access to marijuana will come down to their thoughts on compassion for sick and dying people versus those on preventing drug abuse. It Source: www.freep.com Reasons for Subdued Reaction to Melamine Issue - Digital Chosunilbo The melamine scandal was previously unimaginable. Mix milk with water and add melamine to tick it. Yet dozens of factories in China did just that. Many must have known about it, but kept mute. Many babies died from taking the melamine?tainted Source: english.chosun.com Daiichi Sankyo, Eli Lilly say new blood thinner still on track for FDA - Minneapolis Star Tribune Secret, double life of a Walgreens druggist A nasty bug, an effective (but yucky) cure Running for my life: 1 woman's race against time Strong growth in Medicaid anticipated Hawaii ending universal child health care TOKYO - Japanese drug maker Source: www.startribune.com FDA opening China office to inspect imports - Atlanta Journal Constitution WASHINGTON — The Food and Drug Administration will establish its first office in China before the end of the year as part of a broader plan to assure the safety of imports from the developing world. FDA Commissioner Andrew von Eschenbach on Source: www.ajc.com Report attacks FDA's BPA assessment - United Press International WASHINGTON, Oct. 25 (UPI) -- A U.S. Food and Drug Administration assessment of bisphenol-A was based on plastics industry reports, The Milwaukee Journal Sentinel said. The newspaper said internal FDA documents show a report commissioned by the Source: www.upi.com 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. 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". The Hartz Mountain Corporation Voluntarily Recalls One Specific Lot of Nationwide Chicken-Basted Rawhide Chips Because of Possible Health Risk (October 20) The Hartz Mountain Corporation, Secaucus, NJ is voluntarily recalling one specific lot of Hartz Chicken-Basted Rawhide Chips due to concerns that one or more bags within the lot are potentially contaminated with Salmonella. Hartz is fully cooperating with the US Food and Drug Administration in this voluntary recall. Over The Counter Cough and Cold Medications Product labels being modified to state "do not use" in children under 4 years of age. 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. 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. Tiotropium (marketed as Spiriva HandiHaler) UPDATE - Preliminary results of the UPLIFT Trial shows no increased risk of stroke with tiotropium bromide. Two recent publications reported increased risk for mortality and/or cardiovascular events in patients who received tiotropium or inhaled anticholinergics. Raptiva (efalizumab) Risk of life-threatening infections associated with Raptiva use. 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. October 24, 2008Sector Snap: Diabetes treatment guidelines change - MSN MoneyCentral Sector Snap: Diabetes treatment guidelines change - MSN MoneyCentral
Amylin Pharmaceuticals Inc ( AMLN ) Stock Quote , Chart , News , Add to Watchlist NEW YORK (AP) - New medical industry treatment guidelines could give Eli Lilly & Co.'s and Amylin Pharmaceuticals Inc.'s diabetes drug Byetta a boost as it continues to Source: news.moneycentral.msn.com Medical Lawsuits Put Health At Risk - Forbes On Nov. 3, a day before the election, the U.S. Supreme Court hears Wyeth v. Levine , a case with profound implications for the health of all Americans. In 2000, plaintiff Diane Levine was given Wyeth's anti-nausea drug Phenergan, then on the market Source: www.forbes.com Anti-Obesity Drug Pulled From European Markets - Eflux Media On Thursday, the French pharmaceutical company Sanofi-Aventis halted the sales of their anti-obesity drug called Acomplia throughout Europe , by virtue of health officials’ concerns that the medicine entailed more risks than benefits for those Source: www.efluxmedia.com Antimicrobial Drug Use and Resistance in Europe - Medscape News The material presented here does not necessarily reflect the views of Medscape or companies that support educational programming on www.medscape.com. These materials may discuss therapeutic products that have not been approved by the US Food and Drug Source: www.medscape.com Anti-Obesity Drug Acomplia Gets "Weighed Down" With Bad News - E Canada Now New York (ECN) - Sanofi-Aventis, a French pharmaceutical company began selling its anti-obesity drug Acomplia in Europe in 2006. The appetite reducing drug was used for those patients who have a BMI (body mass index) over 30-kg/m2, as well as those Source: www.ecanadanow.com More Delays For Lilly's Heart Drug - Forbes Prasugrel, an experimental drug that is key to pharmaceutical company Eli Lilly 's future, may be delayed months longer than investors expected. The Food and Drug Administration has asked cardiologists to mark some time in their calendars for a Source: www.forbes.com Power Medical Interventions, Inc. Receives Nasdaq Listing Deficiency - MSN MoneyCentral LANGHORNE, Pa., Oct. 24, 2008 (GLOBE NEWSWIRE) -- Power Medical Interventions(r), Inc. (Nasdaq:PMII), a leader in developing and commercializing Intelligent Surgical Instruments(tm), announced today that it received from the Nasdaq Stock Market a Source: news.moneycentral.msn.com FDA will seek advice on new version of a Genzyme drug - Boston Globe The Food and Drug Administration will ask a panel of experts week whether studies by the Cambridge biotech firm Genzyme Corp. support approval of a new version of its drug Myozyme. Genzyme markets Myozyme for Pompe disease, a rare disorder that Source: www.boston.com Low-sodium products are on the rise - Los Angeles Times Looking to take a pass on at least some salt? A growing number of food companies are coming out with lower-sodium products. Food giant ConAgra recently introduced a line of Orville Redenbacher's popcorn, Smart Pop!, with 30% less sodium than the Source: www.latimes.com Reports of serious drug reactions hit record - Atlanta Journal Constitution The number of serious drug reactions and deaths reported to the government shot up in the first three months of this year to set a new record, a health industry watchdog group said Wednesday. The Food and Drug Administration received nearly 21,000 Source: www.ajc.com European panel gives thumbs up to Celgene's cancer drug Vidaza - Newark Star-Ledger European panel gives thumbs up to Celgene's cancer drug Vidaza - Newark Star-Ledger
A European drug advisory panel has recommended approval of Celgene's Vidaza as a treatment for patients with various blood cancers who are not eligible for stem cell transplants. Brian Branch-Price/AP Celgene's headquarters in Summit The Source: www.nj.com UPDATE 1-Europe gives positive nod to Celgene's Vidaza - Reuters BOSTON, Oct 24 (Reuters) - Advisers to the European Commission recommended approval of the Celgene Corp (CELG.O: Quote , Profile , Research , Stock Buzz ) drug Vidaza as a treatment for a group of blood disorders known as myelodysplastic syndromes Source: www.reuters.com Cancer Drug Vidaza Receives Positive Opinion from European Regulatory - Phramalive.com -- Committee for Medicinal Products for Human Use (CHMP) recommends approval of VIDAZA for treatment of MDS and AML BOUDRY, Switzerland--(BUSINESS WIRE)--Celgene International Sarl (Nasdaq:CELG) today announced that its cancer drug, VIDAZA(R Source: www.pharmalive.com Anti-Obesity Drug Pulled From European Markets - Eflux Media On Thursday, the French pharmaceutical company Sanofi-Aventis halted the sales of their anti-obesity drug called Acomplia throughout Europe , by virtue of health officials’ concerns that the medicine entailed more risks than benefits for those Source: www.efluxmedia.com Watson files Oxytrol patent suit against Barr - Forbes Watson Pharmaceuticals Inc. is suing Barr Pharmaceuticals Inc. to prevent Barr from selling a generic version of the Oxytrol overactive bladder patch, Watson said Friday. The company said it filed a lawsuit against Barr in the U.S. District Court of Source: www.forbes.com 32 products safe, as officials check - Manila Times After milk and dairy products from China, the Bureau of Customs on Friday placed under alert and monitoring all importations of pet food and animal feed from China. The bureau’s move came after the US Food and Drug Administration (FDA) issued a Source: www.manilatimes.net Resolved Drug Shortage: Digoxin oral tablets Resolved Drug Shortage: Digoxin oral tablets
See website for more information about this resolved shortage. Drug Shortages: Drugs to be Discontinued; SecreFlo (porcine secretin for injection, 16 mcg/vial) See Related information section 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 Consumer Alert: Undeclared Sulfites in Shad Raisins (October 6) New York State Agriculture Commissioner alerted consumers that Fatima Brothers Inc. of Maspeth, New York is recalling Shad Raisins due to the presence of undeclared sulfites. The recalled Shad Raisins were packaged in uncoded, 7-ounce plastic bags. Shad Raisins were distributed in New York City. Use Caution With Ayurvedic Products The presence of heavy metals in some Ayurvedic products makes them potentially harmful. 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. Cancer Drug Vidaza(R) Receives Positive Opinion from European - Genetic Engineering News Cancer Drug Vidaza(R) Receives Positive Opinion from European - Genetic Engineering News
-- Acute Myeloid Leukemia (AML) with 20-30 percent blasts and multi-lineage dysplasia, according to World Health Organization (WHO) classification The positive opinion includes important survival data from the AZA-001 trial in higher-risk MDS Source: www.genengnews.com Lilly says EU agency opposes new Cymbalta use - Boston Globe INDIANAPOLIS— A panel of European regulators have recommended against approving antidepressant Cymbalta as a treatment for the pain disorder fibromyalgia, drugmaker Eli Lilly and Co. said Friday. The "negative opinion" comes from the Committee for Source: www.boston.com FDA panel to vote on new version of Genzyme drug - BusinessWeek The Food and Drug Administration will ask a panel of experts next week whether studies by biotech firm Genzyme Corp. support approval of a new version of its drug Myozyme. Cambridge, Mass-based Genzyme already markets Myozyme to patients with Pompe Source: www.businessweek.com Auxilium Pharmaceuticals, Inc. and CPEX Pharmaceuticals, Inc. Receive - MSN MoneyCentral Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL) and CPEX Pharmaceuticals, Inc. (NASDAQ: CPEX) today announced that they have received a notice from Upsher-Smith Laboratories, Inc. advising of the filing by Upsher-Smith Laboratories, Inc. of an Source: news.moneycentral.msn.com Addrenex Pharmaceuticals Initiates Phase 2 Trial on Its Novel - Carolina Newswire DURHAM, N.C. -- Addrenex Pharmaceuticals announced that the U.S. Food and Drug Administration has approved its Investigational New Drug Application (IND) for ADX415, a novel hypertension drug. With the approval, Addrenex has launched a phase 2 Source: carolinanewswire.com FDA will open an outpost in China this year - Boston Globe FDA will open an outpost in China this year - Boston Globe
WASHINGTON - The Food and Drug Administration will establish its first office in China before the end of the year as part of a broader plan to assure the safety of imports from the developing world. FDA Commissioner Andrew von Eschenbach laid out a Source: www.boston.com Meda: FDA Has Accepted for Filing the First Potential Once-a-Day Nasal - Genetic Engineering News The New Drug Application (NDA) for a newly formulated higher strength azelastine nasal spray has now been accepted by the Food and Drug Administration (FDA) as complete for substantive review after initial evaluation. "This product has the potential Source: www.genengnews.com UPDATE 1-US FDA staff cautious on Genzyme's newer Myozyme - Reuters WASHINGTON, Oct 17 (Reuters) - A mass-produced version of Genzyme Corp's (GENZ.O: Quote , Profile , Research , Stock Buzz ) Myozyme showed some similar side effects to a smaller-scale version already on the market, U.S. regulatory staff said in Source: www.reuters.com LAB Research's Hungarian Site Successfully Completes GLP Certificate - Yahoo Finance LAVAL, Quebec, October 24 /PRNewswire/ -- LAB Research Inc. ("LRI" or "LAB Research") (TSX: LRI - News ), a Canadian-based global non-clinical contract research organization ("CRO"), announced that its Hungarian site ("LAB Hungary") successfully Source: biz.yahoo.com Reports of serious drug reactions hit record - Guardian Unlimited Associated Press Writer= WASHINGTON (AP) - The number of serious drug reactions and deaths reported to the government shot up in the first three months of this year to set a new record, a health industry watchdog group said Wednesday. The Food and Source: www.guardian.co.uk Consumer groups call on FDA to test Chilean salmon - Forbes Environmentalists and consumer advocates urged the government Thursday to increase testing of farm-raised salmon from Chile after authorities in Germany detected banned chemicals in Chilean fish. "We obviously have a problem, at least according to Source: www.forbes.com FDA opening China office to inspect imports - Atlanta Journal Constitution WASHINGTON — The Food and Drug Administration will establish its first office in China before the end of the year as part of a broader plan to assure the safety of imports from the developing world. FDA Commissioner Andrew von Eschenbach on Source: www.ajc.com Zeltia's Aplidin proposal wins FDA approval - Reuters MADRID, Oct 24 (Reuters) - Spanish biotechnology group Zeltia (ZEL.MC: Quote , Profile , Research , Stock Buzz ) said on Friday the U.S. Federal Drug Administration has approved the production strategy for its Aplidin drug for solid tumours Source: www.reuters.com Consumer groups call on FDA to test Chilean salmon - Las Vegas Sun Environmentalists and consumer advocates urged the government Thursday to increase testing of farm-raised salmon from Chile after authorities in Germany detected banned chemicals in Chilean fish. "We obviously have a problem, at least according to Source: www.lasvegassun.com FDA Approves Boston Scientific's Carotid Artery Stent - eMaxHealth.com Boston Scientific Corporation (NYSE: BSX) today announced that the U.S. Food and Drug Administration (FDA) has approved its Carotid WALLSTENT Monorail Endoprosthesis for the treatment of patients with carotid artery disease who are at high risk for Source: www.emaxhealth.com Drug Shortage: Fentanyl transdermal patch Drug Shortage: Fentanyl transdermal patch
Availability information updated. Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection) - updated See information in Related Information section. Dextroamphetamine Sulfate 5mg Tablets Drug recall due to the potential for oversized tablets that may be associated with an increased risk of adverse effects. Recalls and Safety Alerts: Avoiding Cardiotoxicity with Mitoxantrone FDA is reemphasizing the importance of monitoring cardiac function in patients treated with mitozantrone, sold as Novantrone and also as a generic. Mitozantrone is used to treat certain patients with prostate cancer, leukemia and multiple sclerosis ... Drug Shortages: Resolved Drug Shortages; Proglycem (diazoxide) oral suspension See Web site for additional information Raptiva (efalizumab) Risk of life-threatening infections associated with Raptiva use. Epoetin alfa Preliminary safety findings from a German clinical trial showed more deaths in patients given epoetin-alpha versus placebo. Drug Shortages: Current Drug Shortages; AMMONUL (sodium phenylacetate and sodium benzoate) Injection 10%/10% See information in Related Information section. Daiichi Sankyo, Eli Lilly: New drug still on track - Forbes Daiichi Sankyo, Eli Lilly: New drug still on track - Forbes
Japanese drug maker Daiichi Sankyo Co. and U.S. partner Eli Lilly & Co. sought to reassure investors Friday that a highly anticipated blood thinner remains on track for approval, despite escalating concerns of further delays by federal health Source: www.forbes.com Reports of serious drug reactions hit record - Guardian Unlimited Associated Press Writer= WASHINGTON (AP) - The number of serious drug reactions and deaths reported to the government shot up in the first three months of this year to set a new record, a health industry watchdog group said Wednesday. The Food and Source: www.guardian.co.uk daily checkup - Lexington Herald-Leader WASHINGTON — The number of serious drug reactions and deaths reported to the government shot up in the first three months of this year to set a record, a health industry watchdog group said Wednesday. The Food and Drug Administration received Source: www.kentucky.com October 23, 2008Consumer groups call on FDA to test Chilean salmon - San Diego Union-Tribune Consumer groups call on FDA to test Chilean salmon - San Diego Union-Tribune
WASHINGTON – Environmentalists and consumer advocates urged the government Thursday to increase testing of farm-raised salmon from Chile after authorities in Germany detected banned chemicals in Chilean fish. “We obviously have a problem, at Source: www.signonsandiego.com More testing urged after German govt finds chemicals in farmed fish - Chicago Tribune WASHINGTON (AP) _ Environmentalists and consumer advocates urged the government Thursday to increase testing of farm-raised salmon from Chile after authorities in Germany detected banned chemicals in Chilean fish. "We obviously have a problem, at Source: www.chicagotribune.com Reports of serious drug reactions hit record - Guardian Unlimited Associated Press Writer= WASHINGTON (AP) - The number of serious drug reactions and deaths reported to the government shot up in the first three months of this year to set a new record, a health industry watchdog group said Wednesday. The Food and Source: www.guardian.co.uk Consumer groups urge FDA to test Chilean salmon - Miami Herald WASHINGTON -- Environmentalists and consumer advocates urged the government Thursday to increase testing of farm-raised salmon from Chile after authorities in Germany detected banned chemicals in Chilean fish. ''We obviously have a problem, at least Source: www.miamiherald.com Zila Demonstrates Effectiveness of Photosensitizing Agent in Animal - MSN MoneyCentral Zila Demonstrates Effectiveness of Photosensitizing Agent in Animal - MSN MoneyCentral
Zila, Inc. ZILAD today announced encouraging preliminary results of an in vivo animal study which showed evidence of photodestruction of premalignant lesions and squamous cell carcinoma when treated with Zila ’ s patented pharmaceutical grade Source: news.moneycentral.msn.com FDA Reports Many More Adverse Drug Reactions - Chattershmatter.com According to the Institute for Safe Medication Practices, the number of deaths as a result of serious drug reactions shot up considerably over the first half of the year. More than 4800 deaths were reported to the Food and Drug Administration in Source: www.chattershmatter.com FDA Continues To Review Safety Of Chantix From Pfizer - dbtechno.com Washington (dbTechno) - The U.S. Food and Drug Administration is reviewing the safety of the anti-smoking drug from Pfizer, Chantix. The FDA has been receiving many reports of accidents that follow the use of the anti-smoking drug. They now want to Source: www.dbtechno.com Oxygen Biotherapeutics, Inc. Reports on FDA Meeting, Next Oxycyte(R - MSN MoneyCentral Oxygen Biotherapeutics, Inc. OXBO today announced that it had a very fruitful and productive scientific meeting with the FDA to discuss the safety and development of Oxycyte ® in Traumatic Brain Injury (TBI). Oxycyte is the Company's perfluorocarbon Source: news.moneycentral.msn.com Lilly CEO: FDA's Prasugrel Review Is 'Very Far Along' >LLY - Wall Street Journal U.S. regulators are "very far along" in their review of Eli Lilly & Co.'s (LLY) application to market an experimental anti-clotting drug, prasugrel, Chief Executive John Lechleiter said Thursday. But Lechleiter, during on a conference call with Source: online.wsj.com Drug Shortages: Current Drug Shortages; AMMONUL (sodium phenylacetate and sodium benzoate) Injection 10%/10% Drug Shortages: Current Drug Shortages; AMMONUL (sodium phenylacetate and sodium benzoate) Injection 10%/10%
See information in Related Information section. Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 (updated) Updated letter on this current drug shortage FDA and PATH Malaria Vaccine Initiative Announce Research Collaboration The U.S. Food and Drug Administration has announced a collaboration with the PATH Malaria Vaccine Initiative (PATH-MVI) to develop laboratory tests to better predict the level of safety and effectiveness of experimental malaria vaccines before they are used in human clinical trials. Drug Shortage: Fentanyl transdermal patch Availability information updated. Dextroamphetamine Sulfate 5mg Tablets Drug recall due to the potential for oversized tablets that may be associated with an increased risk of adverse effects. FDA Licenses for Marketing New Therapy for Rare Genetic Disease The U.S. Food and Drug Administration today licensed for marketing the first product in the United States intended to protect people with hereditary angioedema (HAE), a rare and potentially life-threatening genetic disease. HAE affects about 6,000 to 10,000 individuals in the United States. Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 See Web site for additional information on this current drug shortage FDA Approves Use of Temporary Pump to Assist Heart's Right Side The U.S. Food and Drug Administration approved a Humanitarian Device Exemption (HDE) for the first heart pump that provides certain critically ill patients with temporary support for the right side of their heart. Heart assist devices are mechanical pumps that aid in the pumping action of a weakened heart. Most heart assist devices support the heart's left ventricle, which pumps oxygen-rich blood to the rest of the body. The CentriMag Right Ventricular Assist System is intended for patients requiring support for the heart's right ventricle, which passes oxygen-depleted blood to the lungs to be refreshed with oxygen. 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. Drug Shortage: Drug to be Discontinued; Revex (Nalmefene HCl Injection) Baxter has discontinued Revex production. Adverse drug reactions set record in U.S. - Miami Herald Adverse drug reactions set record in U.S. - Miami Herald
WASHINGTON -- The number of serious drug reactions and deaths reported to the U.S. government shot up in the first three months of this year to set a new record, a health industry watchdog group said Wednesday. The Food and Drug Administration Source: www.miamiherald.com Abbott: FDA Needs More Time To Review TriLipix - CNN Money Continuing a string of drug-approval delays, the U.S. Food and Drug Administration has told Abbott Laboratories (ABT) the agency needs more time to review its experimental cholesterol drug TriLipix, Abbott said Wednesday. The delay, however, may be Source: money.cnn.com FDA delays review of Takeda's heartburn drug - Chicago Tribune It will be a bit longer before consumers see another brand-name prescription heartburn drug on the U.S. market. The Food and Drug Administration has told Deerfield-based Takeda Pharmaceuticals North America Inc. that the agency won't be able to Source: www.chicagotribune.com Study: Drug reactions at record pace - Boston Globe WASHINGTON - The number of serious drug reactions and deaths reported to the government shot up in the first three months of this year to record highs, a health industry watchdog group said yesterday. The Food and Drug Administration received nearly Source: www.boston.com Prescription drug injuries and deaths reach record levels - Los Angeles Times The number of deaths and serious injuries associated with prescription drug use rose to record levels in the first quarter of this year, with 4,825 deaths and nearly 21,000 injuries, a watchdog group said Wednesday. Those numbers represent a nearly Source: www.latimes.com Novartis sues Mylan - Pittsburgh Tribune Review Novartis AG, the Swiss maker of the Diovan hypertension drug, sued Mylan Inc. to prevent it from selling a generic version of the cholesterol pill Lescol. Mylan, the biggest U.S. maker of generic drugs, is seeking Food and Drug Administration Source: www.pittsburghlive.com FDA lifts Boston Scientific's product approval ban - Forbes Boston Scientific said Wednesday the Food and Drug Administration has lifted some restrictions imposed more than two years due to quality control problems. In 2006 the FDA issued the company a rare "corporate warning letter," which barred the Source: www.forbes.com Dynavax and Merck & Co., Inc. Provide Update on U.S. FDA Clinical Hold - MSN MoneyCentral Dynavax Technologies Corporation DVAX and Merck & Co., Inc. have received communication from the U.S. Food and Drug Administration (FDA) regarding the two companies' response to the agency's request for safety information relating to the clinical Source: news.moneycentral.msn.com Drug reaction reports set mark - Philadelphia Inquirer WASHINGTON - The number of serious drug reactions and deaths reported to the government shot up in the first three months of this year to set a record, a health-industry watchdog group said yesterday. The Food and Drug Administration received nearly Source: www.philly.com Mylan Receives Tentative FDA Approval for First-to-File Generic - PR Newswire Mylan Receives Tentative FDA Approval for First-to-File Generic - PR Newswire
PITTSBURGH, Oct. 22 /PRNewswire-FirstCall/ -- Mylan Inc. (NYSE: MYL) today announced that its subsidiary, Mylan Pharmaceuticals Inc., received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Source: sev.prnewswire.com Prescription drug injuries and deaths reach record levels - Los Angeles Times The number of deaths and serious injuries associated with prescription drug use rose to record levels in the first quarter of this year, with 4,825 deaths and nearly 21,000 injuries, a watchdog group said Wednesday. Those numbers represent a nearly Source: www.latimes.com US group urges driving warning for Pfizer's Chantix - Guardian Unlimited WASHINGTON, Oct 22 (Reuters) - Pfizer Inc's smoking-cessation drug Chantix should carry a strong warning about the potential risks of accidental injury and death, U.S. researchers said on Wednesday. Pfizer defended its drug as safe and effective when Source: www.guardian.co.uk October 22, 2008FDA and PATH Malaria Vaccine Initiative Announce Research Collaboration FDA and PATH Malaria Vaccine Initiative Announce Research Collaboration
The U.S. Food and Drug Administration has announced a collaboration with the PATH Malaria Vaccine Initiative (PATH-MVI) to develop laboratory tests to better predict the level of safety and effectiveness of experimental malaria vaccines before they are used in human clinical trials. FDA Approves Updated Labeling for Psoriasis Drug Raptiva The U.S. Food and Drug Administration announced labeling changes, including a Boxed Warning, to highlight the risks of life-threatening infections, including progressive multifocal leukoencephalopathy (PML), with the use of Raptiva (efalizumab). The labeling changes are based on the FDA's post-market surveillance. The FDA is also requiring the submission of a Risk Evaluation and Mitigation Strategy (REMS), which will include a Medication Guide for patients and a timetable for assessment of the REMS. Addressing Questions About Gardasil FDA addresses the safety of Gardasil, a vaccine that prevents infection with types of human papillomavirus (HPV) Drug Shortages: Resolved Drug Shortages; Proglycem (diazoxide) oral suspension See Web site for additional information 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. Better Data Management and More Inspections Are Needed to Strengthen - Phramalive.com Better Data Management and More Inspections Are Needed to Strengthen - Phramalive.com
WASHINGTON, Oct. 22, 2008--FDA databases contain inaccurate information on foreign establishments subject to inspection. FDA uses information from a database of establishments registered to market drugs in the United States and a database of Source: www.pharmalive.com FDA Grants Wider, Full Approval to HIV Drug - Wall Street Journal WASHINGTON -- The Food and Drug Administration granted wider approval to Prezista, a Johnson & Johnson HIV drug, by allowing the medication to be given to newly diagnosed patients, the company said Wednesday. Prezista, a protease inhibitor aimed at Source: online.wsj.com Safety group: Nearly 21,000 cases, including 4,800 deaths, reported to - Minneapolis Star Tribune Safety group: Nearly 21,000 cases, including 4,800 deaths, reported to - Minneapolis Star Tribune
WASHINGTON - The number of serious problems and deaths linked to medications reported to the government set a record in the first three months of this year, a health industry watchdog group said Wednesday. The Food and Drug Administration received Source: www.startribune.com Reports of serious drug reactions - Newsday WASHINGTON - The number of serious drug reactions and deaths reported to the government shot up in the first three months of this year to set a new record, a health industry watchdog group said Wednesday. The Food and Drug Administration received Source: www.newsday.com The Hartz Mountain Corporation Voluntarily Recalls One Specific Lot of Nationwide Chicken-Basted Rawhide Chips Because of Possible Health Risk (October 20) The Hartz Mountain Corporation Voluntarily Recalls One Specific Lot of Nationwide Chicken-Basted Rawhide Chips Because of Possible Health Risk (October 20)
The Hartz Mountain Corporation, Secaucus, NJ is voluntarily recalling one specific lot of Hartz Chicken-Basted Rawhide Chips due to concerns that one or more bags within the lot are potentially contaminated with Salmonella. Hartz is fully cooperating with the US Food and Drug Administration in this voluntary recall. FDA Statement Following CHPA's Announcement on Nonprescription Over-the-Counter Cough and Cold Medicines in Children The steps that are being taken by CHPA will not affect the availability of the medicines, but this voluntary action will result in a transition period where the instructions for use of some OTC cough and cold medicines in children will be different from others. FDA does not typically request removal of OTC products with previous labeling from the shelves during a voluntary label change such as this one. Therefore, some medicines will have the new recommendation "do not use" for children under 4 years of age, while others will instruct that they not be used for children under 2 years of age. If parents or caregivers have or purchase a product that does not have the voluntarily-modified labeling, FDA recommends that they should adhere to the dosage instructions and warnings on the label that accompanies the medication. They should not, under any circumstances, give adult medications to children. If parents or caregivers have questions or are just not sure about how to use a product, they should consult with their doctor or pharmacist. Use Caution With Ayurvedic Products The presence of heavy metals in some Ayurvedic products makes them potentially harmful. 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. JFC International, Inc. Issues Allergy Alert on Undeclared Sulfite in "Kyosai Sengiri Daikon" Dried Radish (October 10) JFC International, Inc. is recalling all products of Kyosai Sengiri Daikon (40/3.50z) due to the present of undeclared sulfite. People who have an allergy or severe sensitivity to sulfite run the risk of life-threatening allergic reaction if they consume this product. FDA Approves Updated Labeling for Psoriasis Drug Raptiva FDA Approves Updated Labeling for Psoriasis Drug Raptiva
The U.S. Food and Drug Administration announced labeling changes, including a Boxed Warning, to highlight the risks of life-threatening infections, including progressive multifocal leukoencephalopathy (PML), with the use of Raptiva (efalizumab). The labeling changes are based on the FDA's post-market surveillance. The FDA is also requiring the submission of a Risk Evaluation and Mitigation Strategy (REMS), which will include a Medication Guide for patients and a timetable for assessment of the REMS. Vaccines Stand Ready for Flu Season FDA has approved six vaccines for the 2008-2009 flu season. Is It Really FDA Approved? Some marketers say their products are "FDA approved", but how can you know for sure? 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. Statin drugs and amyotrophic lateral sclerosis (ALS) Statin drugs and amyotrophic lateral sclerosis (ALS)
New analysis of 41 long-term controlled clinical trials provides evidence that use of statins does not increase incidence of ALS. October 21, 2008FDA Is Faulted for Oversight of Foreign Drugs - Wall Street Journal FDA Is Faulted for Oversight of Foreign Drugs - Wall Street Journal
WASHINGTON -- The Food and Drug Administration is failing to keep accurate data about foreign drug facilities it is supposed to oversee and often doesn't follow up warning letters with inspections, according to a report by the investigative arm of Source: online.wsj.com UPDATE 2-US FDA extends review of Pfizer osteoporosis drug - Reuters WASHINGTON, Oct 21 (Reuters) - U.S. regulators have extended by three months their review of a proposed osteoporosis drug from Pfizer Inc (PFE.N: Quote , Profile , Research , Stock Buzz ) to study the pill in more depth, a company spokeswoman said on Source: www.reuters.com US panel backs Genzyme's new version of Myozyme - Boston Globe WASHINGTON - Genzyme Corp.'s new version of the drug Myozyme should be approved, a US panel said yesterday, even though Food and Drug Administration reviewers reported it may trigger allergic reactions and may not be effective. The panel of FDA Source: www.boston.com Petition calls for FDA to regulate energy drinks - AZCentral.com One hundred scientists and physicians have written a letter to the Food and Drug Administration asking for more regulation of increasingly popular energy drinks because their high caffeine content puts young drinkers at possible risk for caffeine Source: www.azcentral.com Dynavax and Merck & Co., Inc. Provide Update on U.S. FDA Clinical Hold - MSN MoneyCentral Dynavax Technologies Corporation DVAX and Merck & Co., Inc. have received communication from the U.S. Food and Drug Administration (FDA) regarding the two companies' response to the agency's request for safety information relating to the clinical Source: news.moneycentral.msn.com UPDATE 2-US FDA panel backs Genzyme's mass-produced Myozyme - Reuters UPDATE 2-US FDA panel backs Genzyme's mass-produced Myozyme - Reuters
SILVER SPRING, Md., Oct 21 (Reuters) - A mass-produced version of Genzyme Corp's (GENZ.O: Quote , Profile , Research , Stock Buzz ) drug to treat the fatal genetic disorder Pompe disease should be approved as long as further studies are required, a U Source: www.reuters.com Genzyme Tells U.S. FDA Panel That Myozyme Is Safe, Effective - Bloomberg Oct. 21 (Bloomberg) -- Genzyme Corp. 's new version of the drug Myozyme is safe and effective to treat a rare genetic condition called Pompe disease, the company told a U.S. panel. Genzyme asked advisers to the Food and Drug Administration today to Source: www.bloomberg.com U.S. FDA panel backs Genzyme's new Myozyme - Reuters SILVER SPRING, Md., Oct 21 (Reuters) - A mass-produced version of Genzyme Corp's (GENZ.O: Quote , Profile , Research , Stock Buzz ) drug to treat the fatal Pompe disease should be approved as long as further studies are required, a U.S. medical Source: www.reuters.com Genzyme Garners FDA Panel's Nod - Street.Com A Food and Drug Administration advisory panel voted largely in Genzyme's ( GENZ Quote - Cramer on GENZ - Stock Picks ) favor on Tuesday regarding the company's bid to make its Pompe disease drug Myozyme at a new, larger facility. Genzyme shares were Source: www.thestreet.com AVANIR to Present at the BIOCOM Investor Conference - MSN MoneyCentral AVANIR Pharmaceuticals AVNR today announced that Eric Benevich, Vice President of Communications, will present at the third annual BIOCOM Investor Conference on Monday, October 27 at 1:30 p.m. Eastern time (10:30 a.m. Pacific time). This conference Source: news.moneycentral.msn.com US FDA panel backs Genzyme's mass-produced Myozyme - Guardian Unlimited SILVER SPRING, Md., Oct 21 (Reuters) - A mass-produced version of Genzyme Corp's drug to treat the fatal genetic disorder Pompe disease should be approved as long as further studies are required, a U.S. advisory panel said on Tuesday. Data for the Source: www.guardian.co.uk Dynavax and Merck & Co., Inc. Provide Update on U.S. FDA Clinical Hold - MSN MoneyCentral Dynavax Technologies Corporation DVAX and Merck & Co., Inc. have received communication from the U.S. Food and Drug Administration (FDA) regarding the two companies' response to the agency's request for safety information relating to the clinical Source: news.moneycentral.msn.com Dynavax and Merck & Co., Inc. Provide Update on U.S. FDA Clinical Hold - Businesswire.com BERKELEY, Calif. & WHITEHOUSE STATION, N.J.--( BUSINESS WIRE )--Dynavax Technologies Corporation (NASDAQ:DVAX) and Merck & Co., Inc. have received communication from the U.S. Food and Drug Administration (FDA) regarding the two companies' response to Source: www.businesswire.com Petition calls for FDA to regulate energy drinks - USA Today One hundred scientists and physicians have written a letter to the Food and Drug Administration asking for more regulation of increasingly popular energy drinks because their high caffeine content puts young drinkers at possible risk for caffeine Source: www.usatoday.com FDA keeps hold on Dynavax vaccine test - San Francisco Business Journal The Food and Drug Administration told Dynavax Technologies Corp. and its partner Merck & Co. that they can’t restart a clinical trial of a hepatitis B vaccine. The drug, Heplisav, has had its Phase III testing delayed since March, when the FDA put Source: sanfrancisco.bizjournals.com FDA Requires Stronger Fungal Infection Warning for TNF Blockers FDA Requires Stronger Fungal Infection Warning for TNF Blockers
FDA has told the makers of drugs known as "tumor necrosis factor alpha blockers" (TNF-alpha blockers) to strengthen existing labeling. 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. 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. Health Information Advisory on Infant Formula In response to reports of contaminated milk-based infant formula manufactured in China, FDA issued a Health Information Advisory on September 12, 2008. Transvaginal Placement of Surgical Mesh Serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse and stress urinary incontinence. Dextroamphetamine Sulfate 5mg Tablets Drug recall due to the potential for oversized tablets that may be associated with an increased risk of adverse effects. Raptiva (efalizumab) Risk of life-threatening infections associated with Raptiva use. October 2008 Patient Safety News Patient Safety News is a video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. 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. FDA's lax approach to China comes back to bite us - Los Angeles Times FDA's lax approach to China comes back to bite us - Los Angeles Times
» Discuss Article If we've learned anything watching our 401(k)s go down the toilet and the stock market take a pistol-whipping, it's that too-lax regulation and the nowhere-to-hide nature of the global economy leave us vulnerable to all sorts of Source: www.latimes.com FDA Launches Food Defense Awareness Training Kit for Employees in the Food Industry FDA Launches Food Defense Awareness Training Kit for Employees in the Food Industry
Today the U.S. Food and Drug Administration in collaboration with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture launched its food defense awareness training kit for first line food industry employees. The training targets these individuals because they can play an important role in helping to keep our nation's food supply safe, from the farm to the table. 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 See Related information section for updated Letter from Mallinckrodt 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 FDA Approves Use of Temporary Pump to Assist Heart's Right Side The U.S. Food and Drug Administration approved a Humanitarian Device Exemption (HDE) for the first heart pump that provides certain critically ill patients with temporary support for the right side of their heart. Heart assist devices are mechanical pumps that aid in the pumping action of a weakened heart. Most heart assist devices support the heart's left ventricle, which pumps oxygen-rich blood to the rest of the body. The CentriMag Right Ventricular Assist System is intended for patients requiring support for the heart's right ventricle, which passes oxygen-depleted blood to the lungs to be refreshed with oxygen. Drug Shortages: Current Drug Shortages; Phospholine Iodide, Ophthalmic solution See Web site for additional information on this current drug shortage FDA Statement Following CHPA's Announcement on Nonprescription Over-the-Counter Cough and Cold Medicines in Children The steps that are being taken by CHPA will not affect the availability of the medicines, but this voluntary action will result in a transition period where the instructions for use of some OTC cough and cold medicines in children will be different from others. FDA does not typically request removal of OTC products with previous labeling from the shelves during a voluntary label change such as this one. Therefore, some medicines will have the new recommendation "do not use" for children under 4 years of age, while others will instruct that they not be used for children under 2 years of age. If parents or caregivers have or purchase a product that does not have the voluntarily-modified labeling, FDA recommends that they should adhere to the dosage instructions and warnings on the label that accompanies the medication. They should not, under any circumstances, give adult medications to children. If parents or caregivers have questions or are just not sure about how to use a product, they should consult with their doctor or pharmacist. FDA Licenses Drug to Prevent Joint Damage in Children with Hemophilia A The U.S. Food and Drug Administration today approved a new use for the blood product Kogenate FS to reduce the frequency of bleeding episodes and prevent joint damage in children with the most severe form of hemophilia. Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection) - updated See information in Related Information section. OXiGENE Announces Clinical Trials Interim Data Update to be Presented - MSN MoneyCentral OXiGENE Announces Clinical Trials Interim Data Update to be Presented - MSN MoneyCentral
ZYBRESTAT (fosbretabulin) is currently being evaluated in a pivotal registration study as a potential treatment for anaplastic thyroid cancer (ATC) under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration (FDA). Phase Source: news.moneycentral.msn.com FDA wants more data on extended-release Vicodin - Arlington Heights Daily Herald Abbott Laboratories said Monday the Food and Drug Administration requested more information on the controlled-release form of its painkiller Vicodin. Abbott said the FDA sent a "complete response letter," which the company will discuss with the Source: www.dailyherald.com FDA will look into possible conflict - Forbes The Food and Drug Administration said Tuesday it will look into concerns that a prominent toxicologist asked to render an independent verdict on a sensitive consumer safety issue may have a financial conflict-of-interest. But an FDA official said Source: www.forbes.com October 20, 2008FDA Approves Updated Labeling for Psoriasis Drug Raptiva FDA Approves Updated Labeling for Psoriasis Drug Raptiva
The U.S. Food and Drug Administration announced labeling changes, including a Boxed Warning, to highlight the risks of life-threatening infections, including progressive multifocal leukoencephalopathy (PML), with the use of Raptiva (efalizumab). The labeling changes are based on the FDA's post-market surveillance. The FDA is also requiring the submission of a Risk Evaluation and Mitigation Strategy (REMS), which will include a Medication Guide for patients and a timetable for assessment of the REMS. Tristar Food Wholesale Co Inc. Issues a Nationwide recall of Blue Cat Flavor Drink Because of Possible Health Risk (October 3) Tristar Food, Jersey City, NJ is initiating a nationwide recall of all of their 100 ml plastic bottle packages of Blue Cat Flavor Drink (Lanmao) because it may be contaminated with Melamine. Is It Really FDA Approved? Some marketers say their products are "FDA approved", but how can you know for sure? 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. Safety and Food Packaging FDA monitors all packaging that comes into contact with food. Here's an overview of how FDA conducts safety reviews of food contact substances. Barry Callebaut USA LLC Issues Allergen Alert on Undeclared Milk Protein in Kroger Value Semi Sweet Chocolate Chips (October 10) Barry Callebaut USA LLC Issues Allergen Alert on Undeclared Milk Protein in Kroger Value Semi Sweet Chocolate Chips (October 10)
Barry Callebaut USA LLC is conducting a voluntary recall on its product sold by Kroger Stores under the brand "Kroger Value Semi Sweet Chocolate Chips", 12 oz., UPC Code is 11110–86603 and "sell by" date May 30, 2010, as the product may contain undeclared milk protein. The "sell by" date is found printed in black on the end of the bag. People with allergies or severe sensitivity to milk protein may be at risk of serious or life-threatening allergic reaction if they consume this product. Bimbo Bakeries USA Issues an Allergy Alert on Undeclared Tree Nuts in Oroweat 100 Percent Whole Wheat Bread Packaging (September 16) Bimbo Bakeries USA today announced a voluntary recall of Oroweat 100 Percent Whole Wheat bread because it may contain tree nuts that are not listed on the label. Individuals with allergies to tree nuts run the risk of a serious and or life threatening reaction if they consume this product. 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. 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. FDA Approves Updated Labeling for Psoriasis Drug Raptiva The U.S. Food and Drug Administration announced labeling changes, including a Boxed Warning, to highlight the risks of life-threatening infections, including progressive multifocal leukoencephalopathy (PML), with the use of Raptiva (efalizumab). The labeling changes are based on the FDA's post-market surveillance. The FDA is also requiring the submission of a Risk Evaluation and Mitigation Strategy (REMS), which will include a Medication Guide for patients and a timetable for assessment of the REMS. McCormick and Company Has Recalled McCormick Enchilada Sauce Mix Due To Unlabeled Milk Ingredients (September 30) The McCormick Enchilada Sauce Mix was distributed to grocery stores nationally beginning on September 17, 2008. The product comes in 1.5 oz. pouches with an expiration date of "best by" AUG2910CH. The date is found printed in black on the back, bottom left of the pouch. Addressing Questions About Gardasil FDA addresses the safety of Gardasil, a vaccine that prevents infection with types of human papillomavirus (HPV) Sector Snap: Diabetes drug developers gain ground - Forbes Sector Snap: Diabetes drug developers gain ground - Forbes
A regulatory delay for Takeda Pharmaceuticals developing diabetes drug alogliptin helped boost shares of competitor Merck & Co. Monday, highlighting the competitive nature of diabetes drug development within the pharmaceutical and biotech sectors Source: www.forbes.com Elan and Transition Therapeutics Achieve Patient Enrollment Target in - PR Inside ELND005 is an orally-administered therapeutic agent that has received fast track designation from the U.S. Food and Drug Administration (FDA) for treatment of mild to moderate Alzheimer's disease. Fast track designation facilitates development and Source: www.pr-inside.com Raptor Pharmaceuticals Announces Phase 2a Clinical Trial Initiation in - MSN MoneyCentral NOVATO, California , October 20 /PRNewswire/ -- Raptor Pharmaceuticals Corp. ("Raptor" or the "Company") (OTC Bulletin Board: RPTP), today announced the initiation of patient dosing in a Phase 2a clinical trial, in collaboration with the University Source: news.moneycentral.msn.com ADVENTRX Announces Restructuring and Cost Reduction Initiatives - MSN MoneyCentral SAN DIEGO , Oct. 20 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. ANX announced today that it has implemented a restructuring designed to reduce operating costs while continuing advancement towards the Company's near term goals. ADVENTRX Source: news.moneycentral.msn.com UPDATE 1-Takeda says U.S. delays ulcer drug decision - Reuters TOKYO, Oct 20 (Reuters) - Japan's Takeda Pharmaceutical Co (4502.T: Quote , Profile , Research , Stock Buzz ) said U.S. regulators have pushed back the possible approval of a key drug candidate, the latest in a string of delays in the world's largest Source: www.reuters.com Takeda says FDA delays decision on ulcer drug - CNBC TOKYO, Oct 20 (Reuters) - Takeda Pharmaceutical Co, Japan's largest drugmaker, said on Monday U.S. regulators have put back the date for a response to Takeda's application for approval of a key ulcer drug candidate due to a delay in the examination Source: www.cnbc.com Don't handcuff scientists - Boston Globe IT'S Nobel Prize season to reward medical breakthroughs, and the Lasker Foundation recently conferred its "American Nobel," the DeBakey-Lasker Award for Clinical Research, on biochemist Akira Endo for his discovery in 1976 of the first statin, a Source: www.boston.com Food fear factor - Boston Globe The "Shop the World" grocery aisles may seem like a perilous place these days. Two years ago, government inspectors discovered poisonous tuna steaks from Vietnam. Then came salmonella-tainted cantaloupes from Costa Rica. This summer, it was Source: www.boston.com FDA Adds Three Months to Review of Takeda's New Drug Application for - TradingMarkets.com "The FDA informed Takeda that it will require an additional three months to complete the review of the TAK-390MR NDA," said Dean Sundberg, senior vice president, regulatory affairs at Takeda Global Research and Development Center, Inc. "Takeda has Source: www.tradingmarkets.com Improper Use of Decorative Contacts May Haunt You 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 Ammonul (sodium phenylacetate and sodium benzoate) Injection 10%/10% Particulate matter detected in product. Healthcare providers instructed to use a filter during the admixture process. Recalls and Safety Alerts: Avoiding Cardiotoxicity with Mitoxantrone FDA is reemphasizing the importance of monitoring cardiac function in patients treated with mitozantrone, sold as Novantrone and also as a generic. Mitozantrone is used to treat certain patients with prostate cancer, leukemia and multiple sclerosis ... Raptiva (efalizumab) Risk of life-threatening infections associated with Raptiva use. 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. Recalls and Safety Alerts: Update on Cardiopulmonary Reactions with Ultrasound Micro-bubble Contrast Agents FDA is alerting healthcare professionals about labeling changes for ultrasound micro-bubble contrast agents, which are sold as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injec... October 19, 2008Family Blames Soldier's Suicide on Anti-Malaria Drug - Washington Post Family Blames Soldier's Suicide on Anti-Malaria Drug - Washington Post
Susana Ferro, shown with her son Juan "John" Torres before he deployed for Afghanistan, blames the anti-malaria drug Lariam for his 2004 suicide. (Courtesy of Susana Ferro) CHICAGO -- Juan Torres didn't believe that his son, Army Reservist Juan "John Source: www.washingtonpost.com Family faults antimalaria drug in suicide - Boston Globe CHICAGO - Juan Torres did not believe that his son, Army Reservist Juan "John" Torres, had killed himself in Afghanistan just weeks before he was to return home in July 2004. He figured that John, 25, was murdered because of his opposition to the Source: www.boston.com FDA approves new labeling for psoriasis drug Raptiva - News-Medical.Net The U.S. Food and Drug Administration today announced labeling changes, including a Boxed Warning, to highlight the risks of life-threatening infections, including progressive multifocal leukoencephalopathy (PML), with the use of Raptiva (efalizumab Source: www.news-medical.net FDA approves Astepro, new formulation of Astelin - News-Medical.Net The U.S. Food and Drug Administration (FDA) has approved Astepro - the new formulation of Astelin. Astepro Nasal Spray is an improvement over the marketed Astelin Nasal Spray and is better tolerated by patients using the new spray. The active Source: www.news-medical.net BioTrove Announces Agreement with BD to Boost Drug Discovery Research - Forbes BioTrove, Inc. today announced an exclusive alliance with BD (Becton, Dickinson and Company) to provide customers with a complete solution for sample preparation and data analysis of high-throughput in vitro ADME assays. BD CYP450 Inhibition Source: www.forbes.com Medtronic's Third-Generation Endeavor(R) Resolute Drug-Eluting Stent - MSN MoneyCentral Of those treated with the Endeavor ® Resolute drug-eluting stent (DES) from Medtronic, Inc. MDT , in the RESOLUTE IDE trial only two patients required repeat procedures – a remarkably low 1.5 percent rate of target lesion revascularization (TLR Source: news.moneycentral.msn.com Sector Snap: Diabetes drug developers gain ground - CNBC NEW YORK - A regulatory delay for Takeda Pharmaceuticals developing diabetes drug alogliptin helped boost shares of competitor Merck & Co. Monday, highlighting the competitive nature of diabetes drug development within the pharmaceutical and biotech Source: www.cnbc.com Canada to ban baby bottles with BPA - MSNBC TORONTO - Canada declared a chemical widely used in food packaging a toxic substance and will now move to ban plastic baby bottles containing bisphenol A. The toxic classification, issued in the Canada Gazette on Saturday, makes Canada the first Source: www.msnbc.msn.com Living Well: How much mercury is safe? Go fishing for answers - Seattle Post Intelligencer Here's a fundamental problem regarding mercury levels in the fish we eat, according to Dr. Jane Hightower: No authoritative governing body can agree on how much mercury is too much, both for expectant mothers (also women trying to become pregnant Source: seattlepi.nwsource.com Drug makers cut back on ads - Honolulu Advertiser Drug makers cut back on ads - Honolulu Advertiser
NEW YORK — This could make media owners sick: Pharmaceutical ad spending they count on to exceed $5 billion a year is losing its potency. Two recent reports say drugmakers cut ad spending in the first six months of this year. TNS Media Intelligence Source: www.honoluluadvertiser.com Medtronic's Third-Generation Endeavor(R) Resolute Drug-Eluting Stent - MSN MoneyCentral Of those treated with the Endeavor ® Resolute drug-eluting stent (DES) from Medtronic, Inc. MDT , in the RESOLUTE IDE trial only two patients required repeat procedures – a remarkably low 1.5 percent rate of target lesion revascularization (TLR Source: news.moneycentral.msn.com MOVES could revolutionize medevacs - Marine Corp Times The Corps is developing an emergency care system that will remove explosive oxygen canisters from battlefield aircraft and potentially revolutionize civilian emergency medicine, Marine officials said. Pending approval by the Food and Drug Source: www.marinecorpstimes.com Family Blames Soldier's Suicide on Anti-Malaria Drug - Washington Post Susana Ferro, shown with her son Juan "John" Torres before he deployed for Afghanistan, blames the anti-malaria drug Lariam for his 2004 suicide. (Courtesy of Susana Ferro) CHICAGO -- Juan Torres didn't believe that his son, Army Reservist Juan "John Source: www.washingtonpost.com States ask baby product companies to avoid BPA - Newsday HARTFORD, Conn. - Connecticut 's attorney general on Monday said the U.S. Food and Drug Administration was "asleep at the switch" by failing to take action against companies that use the chemical bisphenol A in making baby bottles and baby formula Source: www.newsday.com Abbott's XIENCE V(TM) Drug Eluting Stent Outperforms TAXUS(R) in Key - MSN MoneyCentral New Analysis of SPIRIT II and SPIRIT III Data Confirms Patients Treated with XIENCE V Are at Lower Risk of Experiencing Death, a Heart Attack or a Repeat Procedure Compared to TAXUS(R) at Two Years WASHINGTON , Oct. 13 /PRNewswire-FirstCall/ -- Data Source: news.moneycentral.msn.com Ban on baby bottles with chemical - Times of India TORONTO: Canada has declared a chemical widely used in food packaging a toxic substance and will move to ban the sale in Canada of plastic baby bottles containing bisphenol A. The toxic classification, issued in Saturday's Canada Gazette, makes Source: timesofindia.indiatimes.com Family faults antimalaria drug in suicide - Boston Globe CHICAGO - Juan Torres did not believe that his son, Army Reservist Juan "John" Torres, had killed himself in Afghanistan just weeks before he was to return home in July 2004. He figured that John, 25, was murdered because of his opposition to the Source: www.boston.com BioTrove Announces Agreement with BD to Boost Drug Discovery Research - Forbes BioTrove, Inc. today announced an exclusive alliance with BD (Becton, Dickinson and Company) to provide customers with a complete solution for sample preparation and data analysis of high-throughput in vitro ADME assays. BD CYP450 Inhibition Source: www.forbes.com Sector Snap: Diabetes drug developers gain ground - Forbes A regulatory delay for Takeda Pharmaceuticals developing diabetes drug alogliptin helped boost shares of competitor Merck & Co. Monday, highlighting the competitive nature of diabetes drug development within the pharmaceutical and biotech sectors Source: www.forbes.com States ask baby product companies to avoid BPA - Newsday States ask baby product companies to avoid BPA - Newsday
HARTFORD, Conn. - Connecticut 's attorney general on Monday said the U.S. Food and Drug Administration was "asleep at the switch" by failing to take action against companies that use the chemical bisphenol A in making baby bottles and baby formula Source: www.newsday.com Family Blames Soldier's Suicide on Anti-Malaria Drug - Washington Post Susana Ferro, shown with her son Juan "John" Torres before he deployed for Afghanistan, blames the anti-malaria drug Lariam for his 2004 suicide. (Courtesy of Susana Ferro) CHICAGO -- Juan Torres didn't believe that his son, Army Reservist Juan "John Source: www.washingtonpost.com FDA opening China office to inspect imports - Atlanta Journal Constitution FDA opening China office to inspect imports - Atlanta Journal Constitution
WASHINGTON — The Food and Drug Administration will establish its first office in China before the end of the year as part of a broader plan to assure the safety of imports from the developing world. FDA Commissioner Andrew von Eschenbach on Source: www.ajc.com Orthofix International Benefits From Recent Agreements And FDA - MSN MoneyCentral Orthofix International N.V. OFIX (the Company) commented today on recent events expected to enhance the Company ’ s financial strength and outlook, and announced its participation at the Annual Meeting of the North American Spine Society (NASS) in Source: news.moneycentral.msn.com Integrated Medical Systems Receives FDA Clearance for World's First - Forbes SIGNAL HILL, Calif., Oct. 13 /PRNewswire/ -- Integrated Medical Systems, Inc., a medical technology systems integrator developing fully integrated products for critical care, announced today that it has received 510(k) clearance from the U.S. Food Source: www.forbes.com Joining family firm can be daunting - Boston Globe Charles River Laboratories Inc. in Wilmington, the world's largest supplier of laboratory rats and mice, is increasingly generating revenue by running animal tests for pharmaceutical companies. The company had $1.2 billion in revenue last year and 60 Source: www.boston.com India: U.S. Pharma Behind Ranbaxy Ban? - BusinessWeek By Vikas Bhardwaj and Khomba Singh The Union health ministry has come to the defence of Ranbaxy, alleging that vested interests were behind the US ban on 30 drugs of the Indian pharma major. The US Food and Drug Administration (FDA) was being Source: www.businessweek.com Drug Companies: No Cold Medicines For Kids Under 4 - WWJ Newsradio 950 (CBS/AP) Children under 4 should not be given cough and cold medicines, companies that make those products said Tuesday in announcing new guidelines for their use. The industry has been criticized by pediatricians for marketing over-the-counter cough Source: www.wwj.com Canada says BPA toxic, to ban baby bottles with it - FOX News Canada says BPA toxic, to ban baby bottles with it - FOX News
TORONTO — Canada declared a chemical widely used in food packaging a toxic substance on Saturday and will now move to ban plastic baby bottles containing bisphenol A. The toxic classification, issued in the Canada Gazette, makes Canada the first Source: www.foxnews.com States ask baby product companies to avoid BPA - Seattle Post Intelligencer HARTFORD, Conn. -- Attorneys general from Connecticut, New Jersey and Delaware sent letters Friday to 11 companies that make baby bottles and baby formula containers, asking they no longer use the chemical bisphenol A in their manufacturing because Source: seattlepi.nwsource.com Injection recall list expanded - China Economic Net The Chinese producer of the deadly "ciwujia" herbal injection decided on Friday to recall all its injection products, expanding its previous recall list, the national drug safety watchdog said on Saturday. The Ministry of Health and the State Food Source: en.ce.cn Family Blames Soldier's Suicide on Anti-Malaria Drug - Washington Post Susana Ferro, shown with her son Juan "John" Torres before he deployed for Afghanistan, blames the anti-malaria drug Lariam for his 2004 suicide. (Courtesy of Susana Ferro) CHICAGO -- Juan Torres didn't believe that his son, Army Reservist Juan "John Source: www.washingtonpost.com Promotional ADHD drug video draws FDA’s rebuke - Philadelphia Business Journal Ty Pennington with Shire Chairman Matt Emmens last year. WAYNE — A YouTube video featuring a reality television personality touting a Shire attention-deficit disorder drug has gotten the pharmaceutical company in trouble with the Food and Drug Source: philadelphia.bizjournals.com Behind-the-scenes talks prompted drug industry to adopt FDA - Minneapolis Star Tribune WASHINGTON - When drug makers made a surprise announcement this week that they no longer recommend cough and cold remedies for youngsters under 4, they didn't let on that it was the government's idea. And why age 4 rather than the age 6 that Source: www.startribune.com |
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