FDA May Modify Orphan Exclusivity Reg, But Label Carve-Out Policy Is Intact
Executive Summary
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.
You may also be interested in...
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.
FDA’s Orphan Exclusivity Requirement For “Clinical Superiority” Challenged In Court
Depomed argues in a suit against FDA that it should not have to show Gralise (gabapentin) is clinically superior to Neurontin since Neurontin never received an orphan drug designation or orphan exclusivity.
A Visual Guide To How FDA Can Manage The Pandemic
Our infographic illustrates the recommendations in FDA’s COVID-19 pandemic recovery and preparedness plan, ranging from strengthening the EUA process to managing the backlog of pending inspections.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: