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Eagle Wins Orphan Drug Status In Row With FDA

Law360 (June 11, 2018, 7:18 PM EDT) -- A D.C. federal judge came down on the side of Eagle Pharmaceuticals Inc. on Friday, ordering the U.S. Food and Drug Administration to grant orphan drug exclusivity to the company's chemotherapy drug Bendeka.

The ruling looks to end two years of litigation over the orphan drug status of Bendeka, which is used to treat certain kinds of leukemia and non-Hodgkins lymphoma, and over whether the drug would be granted a seven-year period of marketing exclusivity from the FDA. U.S. District Judge Timothy J. Kelly came down on the side of Eagle on Friday and denied the FDA’s own motion for summary...

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April 27, 2016

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