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High Blood Pressure Medicine Diovan Gets Six Months Additonal Marketing Exclusivity from FDA
Diovan (valsartan) has been granted pediatric exclusivity by the US Food and Drug Administration (FDA) based on studies conducted in children with hig...

FDA Approves of Pfizer's AIDS Drug Selzentry
AIDS Healthcare Foundation (AHF) welcomed news that the FDA has approved Pfizer Inc.'s new AIDS salvage therapy, Selzentry (maraviroc), a different cl...

Rilonacept (IL-1 Trap) Granted FDA Priority Review for the Treatment of CAPS
Regeneron Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and granted priority review status to the...

Escape Velocity Systems Demonstrates Compliance with FDA 21 CFR Part 11 Requirements
The FDA specifically states that the "agency expects the magnitude of these benefits should significantly outweigh the costs of making these system."A...

FDA Approves Novel Antiretroviral Drug
The U.S. Food and Drug Administration (FDA) approved maraviroc, an antiretroviral drug for use in adult HIV patients. Maraviroc, sold under the trade ...

FDA Warns of Potential Botulism Risk from Canned French Cut Green Beans
The U.S. Food and Drug Administration (FDA) is warning consumers not to eat certain brands of French Cut Green Beans in 14.5 ounce cans manufactured b...

FDA, Defense Department Share Data to Enhance Medical Product Safety Reviews
Data from the U.S. Military Health System will soon help the U.S. Food and Drug Administration make decisions affecting the safety and use of FDA-regu...

Entelos, FDA to Collaborate on Computer Model to Better Predict Drug-Induced Human Liver Injury
Entelos, a life sciences company building predictive computer models and “virtual patients” for drug discovery and development, today announced th...

Abraxis BioScience's Caffeine Citrate Injection USP, 20 mg/mL gets FDA Approval
Abraxis BioScience, an integrated, global biopharmaceutical company, announced that its hospital-based products business, Abraxis Pharmaceutical Produ...

FDA Announces Program To Enhance States' Food Safety Programs
The U.S. Food and Drug Administration launched a national program to bring about the adoption of more uniform, equivalent, and high quality regulatory...

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