FDA NEWS

FDA says Glaxo drug fails to control bleeding - Los Angeles Times
WASHINGTON -- An experimental drug from GlaxoSmithKline does not significantly lower bleeding in patients with a rare blood disorder, according to the Food and Drug Administration. British drugmaker Glaxo is seeking approval for Promacta to treat a
Source: www.latimes.com

FDA asks Xiadafil VIP Tabs be recalled - The Money Times
Washington -- The U.S. Food and Drug Administration said it has asked SEI Pharmaceuticals of Miami to recall all of its Xiadafil VIP Tabs. The FDA said the recalled drug -- sold in 8 tablet bottles (Lot 6K029) or blister cards of 2 tablets (Lot 6K029
Source: www.themoneytimes.com

Glaxo, Ligand drug gets negative FDA assessment - CNN Money
NEW YORK (Associated Press) - A Food and Drug Advisory Committee said Wednesday GlaxoSmithKline's blood-clotting disorder drug Promacta is no more effective than placebo, sending shares of longtime partner Ligand Pharmaceuticals Inc. plunging to a
Source: money.cnn.com

Watson says Oxybutynin Topical Gel NDA accepted for filing by FDA - Forbes
CORONA, Calif. (Thomson Financial) - Watson Pharmaceuticals , Inc., a specialty pharmaceutical company, announced Wednesday that its New Drug Application (NDA) for oxybutynin chloride topical gel (OTG), has been accepted for filing by the U.S. Food
Source: www.forbes.com

Pfizer Seeks to Counter Chantix Concerns - Wall Street Journal
WASHINGTON -- Pfizer Inc. is preparing an advertising and public-relations campaign to counter concerns about its antismoking drug Chantix, once trumpeted as a potential billion-dollar-a-year blockbuster. Chantix is drawing scrutiny from federal
Source: online.wsj.com

Labs accused of helping food importers beat FDA - Chicago Tribune
WASHINGTON—A congressional committee is investigating whether some private U.S. laboratories were instructed to withhold samples of tainted food so that importers could get their goods into the U.S. In a May 1 letter to 10 labs, the House Committee
Source: www.chicagotribune.com

FDA Orders ED Supplement Recall - WebMD
May 27, 2008 -- Due to a risky ingredient, the FDA has ordered a recall of certain lots of Xiadafil VIP Tabs, an illegally marketed "all-natural" dietary supplement touted for sexual enhancement and erectile dysfunction (ED) treatment. FDA lab tests
Source: www.webmd.com

FDA official sees some delays over safety - Reuters UK
SILVER SPRING, Maryland (Reuters) - A new focus on drug safety is delaying the approval of some medicines as regulators impose requirements meant to minimize side effects, a top U.S. drug regulator told Reuters on Tuesday. The Food and Drug
Source: uk.reuters.com