Eagle Pharmaceuticals Inc. is planning to fight FDA's denial of its request for seven years of orphan drug exclusivity for Bendeka, a liquid, low-volume, short-time infusion formulation of bendamustine for treatment of chronic lymphocytic leukemia and non-Hodgkin lymphoma.
FDA's Orphan Drug Exclusivity Policy May Face Second Court Challenge
FDA denies seven years of orphan drug exclusivity for Eagle Pharmaceuticals' Bendeka (bendamustine) despite district court ruling in Depomed case rejecting agency's "clinical superiority" requirement.
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