2024-11643. Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product; PAXLOVID

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

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.

FOR FURTHER INFORMATION CONTACT:

Cathryn Lee, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-1394, email: [e-mail].

SUPPLEMENTARY INFORMATION:

FDA is announcing the issuance of a material threat MCM priority review voucher to the sponsor of an approved material threat MCM product application. Under section 565A of the FD&C Act (21 U.S.C. 360bbb-4a) FDA will award priority review vouchers to sponsors of approved material threat MCM product applications that meet certain criteria upon approval of those applications. FDA has determined that PAXLOVID (nirmatrelvir co-packaged with ritonavir) tablets, manufactured by Pfizer, Inc., meets the criteria for a material threat MCM priority review voucher. PAXLOVID was approved on May 25, 2023, for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.

For further information about the material threat MCM Priority Review Voucher Program and for a link to the full text of section 565A of the FD&C Act, go to https://www.fda.gov/​emergency-preparedness-and-response/​mcm-legal-regulatory-and-policy-framework/​21st-century-cures-act-mcm-related-cures-provisions#prv. For further information about PAXLOVID (nirmatrelvir co-packaged with ritonavir) tablets go to the “Drugs@FDA” website at https://www.accessdata.fda.gov/​scripts/​cder/​daf/​.

Dated: May 22, 2024.

Lauren K. Roth,

Associate Commissioner for Policy.