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BioWorld - Saturday, April 4, 2026
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Home » Eagle prevails in orphan exclusivity tiff with FDA, providing new clarity for peers
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Eagle prevails in orphan exclusivity tiff with FDA, providing new clarity for peers

March 16, 2020
By Michael Fitzhugh
A U.S. Court of Appeals affirmation of a lower court ruling requiring the FDA to grant Eagle Pharmaceuticals Inc.'s bendamustine infusion product, Bendeka, seven years of orphan drug exclusivity appears to resolve a key piece of uncertainty that had troubled Eagle and others in similar circumstances.
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