FDA's Bendeka decision reverses approvals of Treanda generics

On 20 February 2019 the U.S. Food and Drug Administration (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 District of Columbia Circuit Court in Eagle Pharmaceuticals, Inc. v. Azar, No. 16-790, ECF No. 64 (D.D.C.) (8 June 2018).

At issue following the Eagle decision was whether the exclusivity would block approval of generics to Treanda, a bendamustine product previously approved for the same orphan indications. FDA has decided that generics to Treanda are subject to Bendeka's orphan exclusivity and, therefore, (1) pending abbreviated new drug applications (ANDAs) will not receive final approval until 7 December 2022 (when Bendeka's orphan exclusivity expires), and (2) ANDAs that were approved after 7 December 2015 (the date of Bendeka's approval) will be converted to tentative approval until expiry of the exclusivity.

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