Forest/Lipha Campral Approved On Re-Audit; FDA Backs Off Additional Study Request
This article was originally published in The Pink Sheet Daily
Executive Summary
Alcoholism agent Campral skirts additional trial requirement via re-audit of European data to address data handling concerns, FDA review documents show. Issues of concern include “sloppy” data collection and poorly defined primary endpoints. Re-working of data from three pivotal, non-U.S. studies overturns June 2002 “not approvable” finding.
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