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Aventis Ketek complete response

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

New user fee goal for Aventis' ketolide antibiotic Ketek (telithromycin) is presumably in January, following the firm's July 24 response to a June 1, 2001 "approvable" letter. Aventis submitted data from a 24,000-patient trial comparing Ketek to GlaxoSmithKline's Augmentin (amoxicillin/clavulanate) for the treatment of respiratory tract infection to address FDA's request for additional liver and cardiovascular safety data (Pharmaceutical Approvals Monthly, August 2001, In Brief). FDA's Anti-Infective Drugs Advisory Committee voted against efficacy for community-acquired pneumonia, acute bacterial exacerbation of chronic bronchitis and acute bacterial sinusitis in April 2001, citing QT prolongation and liver toxicity concerns, and requested data from a larger patient populatio
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