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Aventis Ketek

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Data from ten pivotal Phase III trials of telithromycin were presented at the 40th annual Interscience Conference on Antimicrobial Agents and Chemotherapy in Toronto. The trials showed that Ketek had comparable efficacy to comparator antibiotics against community-acquired pneumonia (CAP), acute exacerbation of chronic bronchitis, sinusitis, and phyarygitis/tonsillitis. Aventis submitted an NDA in March for a once-daily dosing regimen for CAP, AECB and acute sinusitis in adults, for pharyngitis/tonsillitis in patients 13 and up and a short-course treatment regimen in all indications except CA
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