[Federal Register Volume 89, Number 103 (Tuesday, May 28, 2024)]
[Notices]
[Page 46139]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-11643]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-2245]


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: 
[email protected].

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.
[FR Doc. 2024-11643 Filed 5-24-24; 8:45 am]
BILLING CODE 4164-01-P