"Shared Exclusivity" Ruling Could Impact Eight First-Time Generics Over Two Years, FDA Says
This article was originally published in The Pink Sheet Daily
Executive Summary
The agency seeks a stay of a court ruling invalidating its "shared exclusivity" policy on paroxetine (Paxil) generics and outlines a number of "new policy determinations" it would have to make if it adopts a "one first applicant" approach instead.