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Asunaprevir NDA Withdrawal Likely To Mean Daclatasvir Delay

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Bristol pulls NDA for its second-generation protease inhibitor, which likely will alter the data needed for approval of its simultaneously filed NS5A inhibitor. Recent approval of daclatasvir in Europe may offer a glimpse at Bristol’s revised U.S. strategy in HCV.

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