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Valeant Responds To Zelapar Approvable Letter, Plans For Mid-2005 Launch

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Valeant responds to Zelapar “approvable” letter for Parkinson’s disease; “complete response” includes two safety studies, as requested in FDA’s 2003 approvable letter for the MAO-B inhibitor. Selegiline safety concerns include drug interactions, hypertension due to “cheese effect”

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