FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: NOTICE OF APPROVAL OF PRODUCT UNDER VOUCHER: RARE PEDIATRIC DISEASE PRIORITY REVIEW VOUCHER; AREXVY (RESPIRATORY SYNCYTIAL VIRUS VACCINE, ADJUVANTED)

WASHINGTON, April 16 -- Food and Drug Administration has issued a notice called: Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted).

The notice was published in the Federal Register on April 16 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: 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...