Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product; PAXLOVID
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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.
Full Text
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<title>Federal Register, Volume 89 Issue 103 (Tuesday, May 28, 2024)</title>
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[Federal Register Volume 89, Number 103 (Tuesday, May 28, 2024)]
[Notices]
[Page 46139]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-11643]
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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.
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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:
<a href="/cdn-cgi/l/email-protection#7b381a0f1309021555371e1e3b1d1f1a55131308551c140d"><span class="__cf_email__" data-cfemail="327153465a404b5c1c7e5757725456531c5a5a411c555d44">[email protected]</span></a>.
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 <a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/21st-century-cures-act-mcm-related-cures-provisions#prv">https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/21st-century-cures-act-mcm-related-cures-provisions#prv</a>. For further information about
PAXLOVID (nirmatrelvir co-packaged with ritonavir) tablets go to the
``Drugs@FDA'' website at <a href="https://www.accessdata.fda.gov/scripts/cder/daf/">https://www.accessdata.fda.gov/scripts/cder/daf/</a>.
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
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