FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: NOTICE OF APPROVAL OF PRODUCT UNDER VOUCHER: RARE PEDIATRIC DISEASE PRIORITY REVIEW VOUCHER; TREMFYA (GUSELKUMAB)

WASHINGTON, April 21 -- Food and Drug Administration has issued a notice called: Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; TREMFYA (guselkumab).

The notice was published in the Federal Register on April 21 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA) is announcing the issuance of approval of a product redeeming a 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 priority rev...