FDA Accepts As "Complete Response" Oscient Pharmaceuticals Corporation (OSCI)'s Submission Following FACTIVE Approvable Letter For Five-Day CAP
11/27/2006 11:04:39 AM
WALTHAM, Mass.--(BUSINESS WIRE)--The U.S. Food and Drug Administration (FDA) has accepted as complete Oscient Pharmaceuticals Corporation’s (Nasdaq: OSCI) response to the FACTIVE® (gemifloxacin mesylate) tablets approvable letter for the application seeking approval for the five-day treatment of community-acquired pneumonia of mild to moderate severity (CAP). FACTIVE is currently approved by the FDA for the five-day treatment of acute exacerbations of chronic bronchitis (AECB) and the seven-day treatment of CAP.
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