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Eagle Will Be Last Firm To Bypass FDA's Orphan Drug Exclusivity Requirement

 
• By Brenda Sandburg

Court orders US FDA to award Bendeka seven years of exclusivity without requiring clinical superiority test; law codifying FDA policy passed prior to suit and is not retroactive.

Courthouse Pillars & Stairs

FDA lost a second legal battle over its orphan drug exclusivity policy. However, the outcome will not benefit other drugs in similar situations since legislation was enacted last year mandating a "clinical superiority test" for an orphan drug that is the "same" as a previously approved drug.

The US District Court for the District of Columbia ordered FDA to award Eagle Pharmaceuticals Inc.'s Bendeka (bendamustine) seven years of orphan drug exclusivity without requiring it to show Bendeka is clinically superior to a previously approved bendamustine product

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