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

This article was originally published in Pharmaceutical Approvals Monthly

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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