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Case Study #1: Replidyne’s Faropenem Program Caught In The Crossfire

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Louisville, Colo.-based Replidyne is particularly invested in the recent FDA draft guidances concerning the use of non-inferiority trial designs in anti-infective studies: the NDA submission for their lead candidate, faropenem medoxomil, is caught in the midst of evolving standards for anti-infective approvals.

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