Campral Approved On Re-Audit, FDA Backs Off Additional Study Request
This article was originally published in Pharmaceutical Approvals Monthly
Forest/Lipha Campral additional clinical trial was not necessary because problems with the original data dealt with handling, not reliability, review documents show. FDA allowed Lipha to conduct a re-audit of three pivotal non-U.S. trials to support approval of the alcoholism treatment. Agency originally requested a new U.S. pivotal trial after deeming the NDA’s original U.S. pivotal "truly a failed study." Issues of concern were "sloppy" data collection, poorly or non-defined primary endpoints, and the potential for multiplicity upon re-analysis of old data
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