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.