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Forest/Lipha acamprosate

Executive Summary

Alcohol abstinence drug acamprosate deemed "not approvable" by FDA, Forest says July 2. The agency is requesting "at least" one additional U.S. safety and efficacy trial and further pharmacokinetic analyses and pre-clinicals. The NDA was based on three European studies from the late-1980s to mid-1990s and one U.S. trial that did not demonstrate efficacy over placebo (1"The Pink Sheet" May 20, p. 25). Forest and Lipha expect a meeting with FDA in August. The NDA was filed in December 2001 and received a priority review...

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