Barr Says Citizen Petition Is Remaining Obstacle To DDAVP Generic Approval
This article was originally published in The Pink Sheet Daily
Executive Summary
Federal court ruling that Sanofi-Aventis patents on desmopressin tablets are invalid and not infringed "effectively ends" 30-month stay of approval on Barr's ANDA for the bed-wetting therapy, generic firm says. A pending citizen petition seeks to establish specific bioequivalence requirements for DDAVP generics.