Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product; PAXLOVID

Issuing agencies

Abstract

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a material threat medical countermeasure (MCM) product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved material threat MCM product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that PAXLOVID (nirmatrelvir co-packaged with ritonavir) tablets, approved on May 25, 2023, manufactured by Pfizer, Inc., meets the criteria for a material threat MCM priority review voucher.