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Oscient responds to Factive CAP "approvable" letter

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA has accepted Oscient's complete response to a September "approvable" letter for the antibiotic Factive (gemifloxacin), the firm announces Nov. 27. The claim for five-day treatment of community acquired pneumonia (CAP) has a new May 1 user fee date. The CAP sNDA was filed in November 2005 and given a standard review with a Sept. 21, 2006 user fee date. Factive is currently approved for five-day treatment of exacerbations of chronic bronchitis and seven-day treatment of CAP. The sNDA was supported by a single Phase III trial comparing five-day and seven-day treatment of acute bacterial sinusitis...

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