FDA News |
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11/19/2009
FDA to Review Actelion's Zavesca for Additional Use
Actelion Ltd, Europe's largest biotech company, said on Thursday the U.S. Food and Drug Administration (FDA) would review use of its drug Zavesca to treat a rare neurodegenerative disease early next y...
Source: Reuters |
11/19/2009
FDA Announces New Warning On Plavix: Avoid Use With Prilosec/Prilosec OTC
Patients should avoid using the stomach acid reducer Prilosec/Prilosec OTC (omeprazole) with the anti-clotting drug Plavix (clopidogrel), the U.S. Food and Drug Administration warned on Nov. 17....
Source: FDA |
11/19/2009
FDA And Everyday Health Collaborate To Expand Reach Of Consumer Health Information
The U.S. Food and Drug Administration (FDA) and Everyday Health Exit Disclaimer today announced a collaboration that will expand the delivery of the agency’s vital consumer health information to the 3...
Source: FDA |
11/19/2009
AstraZeneca PLC (AZN) Asks For U.S. Approval Of Brilinta
AstraZeneca (NYSE: AZN - News) today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ticagrelor, an investigational oral antiplatelet treatme...
Source: PRNewswire |
11/19/2009
ICT Fails To Accelerate Drug Approvals
Drug approvals are taking just as long as they ever did despite increased expenditure on new information technology at the Food and drug Administration. So says a statistical analysis of approval inte...
Source: Inderscience Publishers |
11/18/2009
FDA Grants Emergency Use Authorization To Roche's Assay For 2009 H1N1 Influenza Virus
Roche`s RealTime ready Influenza A/H1N1 Detection Set for the 2009 H1N1 influenza virus has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA). The Roche kit d...
Source: Roche Diagnostics |
11/17/2009
American College of Cardiology/American Heart Association Comment on the FDA Public Health Advisory Regarding a Drug Interaction Between Clopidogrel and Omeprazole
Today the FDA notified healthcare professionals of new safety information concerning a drug interaction between clopidogrel, an anti-clotting medication, and omeprazole, a proton pump inhibitor (PPI)...
Source: American Heart Association; American College of Cardiology |
11/17/2009
Sinovac's PANFLU.1 (H1N1) Regulatory Approval Expanded to Include Geriatric Population
Sinovac Biotech Ltd. , a leading developer and provider of vaccines in China, announced today that it received a revised production license from State Food and Drug Administration for Panflu.1, the Co...
Source: Sinovac Biotech Ltd. |
11/17/2009
American Biotech Labs® Receives FDA Clearance for New Prescription Wound Dressing Gel
ASAP® Antibacterial Silver Wound Dressing Gel is now cleared as a 510(k) medical device "for use in the management of 1st and 2nd degree burns, stasis...pressure...(and) diabetic ulcers, lacerations,...
Source: American Biotech Labs, LLC |
11/17/2009
FDA Grants Emergency Use Authorization To Roche´s Assay For 2009 H1N1 Influenza Virus
Roche`s RealTime ready Influenza A/H1N1 Detection Set for the 2009 H1N1 influenza virus has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA). The Roche kit d...
Source: Roche Diagnostics |
11/17/2009
FDA Says Heartburn Drugs Can Interfere With Plavix
Federal health officials said Tuesday a popular variety of heartburn medications can interfere with the blood thinner Plavix, a drug taken by millions of Americans to reduce risks of heart attack and...
Source: AP |
11/16/2009
NeurogesX Receives FDA Approval of Qutenza? (capsaicin) 8% Patch for Treatment of Postherpetic Neuralgia (PHN)
NeurogesX, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Qutenza? (capsaicin) 8% patch, the first and only product containing prescription strength capsaicin, for...
Source: NeurogesX, Inc. |
11/16/2009
LUSEDRA? (fospropofol Disodium) Injection CIV For Monitored Anesthesia Care (MAC) Sedation Now Available
Eisai Inc. today announced that LUSEDRA? (fospropofol disodium) Injection is now available for use by persons trained in the administration of general anesthesia. LUSEDRA, an aqueous solution, is an i...
Source: Eisai Inc. |
11/16/2009
FDA Finds Bits of Steel, Rubber in Genzyme Drugs
Federal health regulators have found tiny particles of trash in drugs made by Genzyme, the second time this year the biotechnology company has been cited for contamination issues....
Source: AP |
11/13/2009
FDA Approves Lysteda to Treat Heavy Menstrual Bleeding
The U.S. Food and Drug Administration today approved Lysteda tablets (tranexamic acid), the first non-hormonal product cleared to treat heavy menstrual bleeding (menorrhagia). Lysteda works by stabili...
Source: U.S. Food and Drug Administration |
11/13/2009
FDA Begins to Shape Rules for Online Drug, Device Ads
Drug and device makers are urging the FDA to establish clear guidelines that will allow the industry to discuss and promote products in the unsettled world of online social media....
Source: medpageToday |
11/12/2009
Sol-Gel’s IND Application for Rosacea Accepted by FDA
Sol-Gel Technologies announced today that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of Sol-Gel’s Investigational New Drug Application (IND) for DER45-EV Gel for the topical...
Source: BUSINESS WIRE |
11/10/2009
Mylan Receives FDA Approval for Generic Version of Prevacid® Through its Subsidiary Matrix Laboratories
Mylan Inc. today announced that its privately held Indian subsidiary, Matrix Laboratories Limited, has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New...
Source: Mylan Inc. |
11/9/2009
FDA Approves Gloucester Pharmaceuticals, Inc.'s ISTODAX(R) for Patients with Cutaneous T-cell Lymphoma
Gloucester Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) approved ISTODAX® (romidepsin) for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have re...
Source: BUSINESS WIRE |
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