FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: ISSUANCE OF PRIORITY REVIEW VOUCHER; RARE PEDIATRIC DISEASE PRODUCT; KYGEVVI (DOXECITINE AND DOXRIBTIMINE)

WASHINGTON, Jan. 21 -- Food and Drug Administration has issued a notice called: Issuance of Priority Review Voucher; Rare Pediatric Disease Product; KYGEVVI (Doxecitine and Doxribtimine).

The notice was published in the Federal Register on Jan. 21 by Lowell Zeta, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. 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 award ...