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No Shocker Here: Theravance Gets FDA "Complete Response" For Telavancin

This article was originally published in Pharmaceutical Approvals Monthly

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Executive Summary

Theravance is the latest company to be caught in a web created by FDA's ongoing examination of its approach to evaluating new antibiotics. In a move widely anticipated by Wall Street analysts and Theravance alike, FDA sent a "complete response" letter Nov. 27 asking the drug maker for additional data and analyses for its telavancin (Vibativ) application for nosocomial pneumonia

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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