FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: NOTICE OF APPROVAL OF PRODUCT UNDER VOUCHER: MATERIAL THREAT MEDICAL COUNTERMEASURE (MCM) PRIORITY REVIEW VOUCHER; BIXLENVO (BICTEGRAVIR AND LENACAPAVIR)

WASHINGTON, Oct. 28 -- Food and Drug Administration has issued a notice called: Notice of Approval of Product Under Voucher: Material Threat Medical Countermeasure (MCM) Priority Review Voucher; Bixlenvo (Bictegravir and Lenacapavir).

The notice was published in the Federal Register on Oct. 28 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 material threat MCM priority review voucher. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the 21st Century Cures Act (Cures Act), authorizes FDA to award priority review vouchers to sponsors of approved material threat MCM product appl...