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Valeant Responds To Zelapar “Approvable” Letter For Parkinson’s

This article was originally published in The Pink Sheet Daily

Executive Summary

The “complete response” contains two safety studies per FDA’s request. Safety concerns for the fast-dissolving oral selegiline include drug interactions, hypertension due to “cheese effect.” Valeant plans a mid-2005 launch for the MAO-B inhibitor.
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