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”