Orphan Drug Exclusivity: In Narrow Application Of Catalyst Ruling, FDA Retains Its Existing Regs

 
• By Brenda Sandburg

US FDA will continue to tie orphan exclusivity to uses or indications for which the drug was approved. Attorneys say this buys agency time to sort out complex policy and legal questions and continue to seek legislative fix. Additional litigation is also possible, as happened in Depomed case.

Challenge
FDA to go forward with its current orphan drug exclusivity policy but questions remain • Source: Shutterstock

More from US FDA

More from Agency Leadership