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# Court Orders Bendeka Orphan Status
- URL: https://www.fdaweb.com/court-orders-bendeka-orphan-status/
- Published: 2018-06-12T12:00:00.000Z
- Updated: 2026-09-15T00:12:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141665

The DC federal court has ordered FDA to grant seven years of orphan drug exclusivity to Eagle Pharmaceuticals’ Bendeka (bendamustine hydrochloride injection), described as a liquid, low-volume, and short-time 10-minute infusion formulation of bendamustine hydrochloride. The company says that due to the court’s ruling, FDA will not be able to approve any drug applications referencing Bendeka until the exclusivity expires 12/2022.