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Avanir's Reformulated Zenvia Succeeds In Confirmatory Phase III

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

After battling back from a crippling FDA "approvable" letter for Zenvia, its investigational treatment for the sudden and unpredictable emotional outbursts that can accompany neurologic diseases, Avanir is buoyantly predicting a 2010 launch based on positive top-line data from the Phase III confirmatory study it conducted at the agency’s behest.

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