Eagle Will Be Last Firm To Bypass FDA's Orphan Drug Exclusivity Requirement
Executive Summary
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.
You may also be interested in...
FDA's Orphan Drug Exclusivity Policy May Face Second Court Challenge
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 Grants Gralise Orphan Exclusivity But Rejects Policy Change
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.
FDA May Modify Orphan Exclusivity Reg, But Label Carve-Out Policy Is Intact
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.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: