180-Day Generic Exclusivity Decisions Could Follow Norvasc Model, FDA Says
Executive Summary
FDA would like to determine 180-day exclusivity for generic drug applications subject to the Medicare Modernization Act through a case-by-case public notice and comment process, Associate Counsel for Drugs Elizabeth Dickinson told the Generic Pharmaceutical Association policy conference in Washington on Sept. 7
You may also be interested in...
Generic Exclusivity Triggers May Force Re-evaluation Of Brand/Generic Deals
FDA's consideration of how brand/generic settlements would impact generic exclusivity may be causing firms to reconsider the arrangements
Generic Exclusivity Triggers May Force Re-evaluation Of Brand/Generic Deals
FDA's consideration of how brand/generic settlements would impact generic exclusivity may be causing firms to reconsider the arrangements
Generic Exclusivity Debate Continues At FDA: What Counts As A Forfeit?
FDA is continuing its case-by-case review of the 180-day exclusivity status for ANDAs as they approach marketing - most recently for generics of Bayer's Precose (acarbose), King's Altace (ramipril) and Roche's Kytril (granisetron)