Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted)

Issuing agencies

Abstract

The Food and Drug Administration (FDA) is announcing the approval of a product redeeming a rare pediatric disease priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the issuance of rare pediatric disease priority review vouchers as well as the approval of products redeeming vouchers. FDA has determined that AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted), BLA supplement approved June 7, 2024, meets the criteria for redeeming a priority review voucher.