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FDA’s Bendeka decision reverses approvals of Treanda generics

21 February 2019

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...

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Regulatory Exclusivities, Hatch-Waxman, and Similar Statutes

FDA’s Bendeka decision reverses approvals of Treanda generics

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