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
You may also be interested in...
Cosmetic And Personal Care Trademark Review: 16 April
Personal care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3.
Health And Wellness Weekly Trademarks Review: 16 April
Trademarks are registered and published for opposition with the US Patent and Trademark Office and are published weekly in the agency's Official Gazette.
Beauty Packaging Producers: July Marks Registration Deadline With PRO In Three States
Companies considered producers of single-use packaging in Oregon, Colorado and California must register with Circular Action Alliance, the leading (and currently only) producer responsibility organization, by 1 July 2024 under new state recycling laws.