FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: NOTICE OF APPROVAL OF PRODUCT UNDER VOUCHER: RARE PEDIATRIC DISEASE PRIORITY REVIEW VOUCHER; KEYTRUDA QLEX (PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH)

WASHINGTON, Dec. 19 -- Food and Drug Administration has issued a notice called: Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph).

The notice was published in the Federal Register on Dec. 19 by Lowell M. Zeta, Acting 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 p...