Eagle Will Be Last Firm To Bypass FDA's Orphan Drug Exclusivity Requirement
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.
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FDA denies seven years of orphan drug exclusivity for Eagle Pharmaceuticals' Bendeka (bendamustine) despite district court ruling in Depomed case rejecting agency's "clinical superiority" requirement.
FDA bows to a court ruling requiring it to award orphan drug market exclusivity to Depomed’s gabapentin, but the agency says it will continue to require the sponsor of a drug that is the “same” as a previously approved drug to show that it is “clinically superior” in order to be eligible.
A district court rejects FDA’s “clinical superiority” requirement for Gralise orphan exclusivity, while another court upholds the agency’s finding that an ANDA label carve-out may overlap partially with a protected method of use.