FDA Approves Product Under Voucher for Rare Pediatric Disease Priority Review Voucher

Summary

The FDA has approved a product redeeming a priority review voucher for AJOVY (fremanezumab-vfrm), a rare pediatric disease treatment, following the issuance of a notice as required by law. The approval was made possible by the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Food and Drug Administration Safety and Innovation Act (FDASIA).