March 13, 2020 / 8:41 PM / 24 days ago

Eagle Pharma beats FDA on appeal over orphan drug marketing exclusivity

A federal appeals court on Friday ruled that the Food and Drug Administration wrongly failed to grant Eagle Pharmaceuticals Inc seven years of marketing exclusivity for its cancer treatment Bendeka after designating it as an “orphan drug” for rare diseases.

The U.S. Court of Appeals for the District of Columbia Circuit by a 2-1 vote held the Orphan Drug Act entitles drugmakers to the marketing exclusivity period if the FDA designates a medication as an orphan drug and later approves it.

To read the full story on WestlawNext Practitioner Insights, click here: bit.ly/3aUb62p

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