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Focus on Regulation

Tag Archives: orphan drug exclusivity

FDA’s Bendeka decision reverses approvals of Treanda generics

Yesterday, FDA released a letter stating how the agency intends to implement the scope of orphan drug exclusivity awarded to Eagle Pharmaceuticals’ Bendeka (bendamustine HCl) by the D.C. Circuit Court in Eagle Pharmaceuticals, Inc. v. Azar, No. 16-790, ECF No. 64 (D.D.C.) (Jun. 8, 2018).  At issue following the Eagle decision was whether the exclusivity