Federal Register #2026-07368

FDA Approval of AREXVY (RSV Vaccine) under Rare Pediatric Disease Priority Review Voucher Program

This announcement details the FDA's approval of AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) under the Rare Pediatric Disease Priority Review Voucher program. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEM/Vendor: - AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) - Products/Services: - Approval of a Biologics License Application (BLA) supplement for AREXVY - No procurement of products or services is requested - No part numbers or quantities specified - Unique/Notable Requirements: - Approval is granted under the Rare Pediatric Disease Priority Review Voucher program, which incentivizes development of treatments for rare pediatric diseases - This is a regulatory approval notice, not a solicitation for procurement

Description

The Food and Drug Administration (FDA) announces the approval of AREXVY, a Respiratory Syncytial Virus Vaccine, Adjuvanted, which redeems a rare pediatric disease priority review voucher. This approval follows the Federal Food, Drug, and Cosmetic Act provisions that award priority review vouchers to sponsors of approved rare pediatric disease product applications meeting specific criteria. The approval was granted as a Biologics License Application supplement on June 7, 2024. The notice serves to inform the public of the product's approval under the voucher program.

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