Notice of Approval of Product Under Voucher: Material Threat Medical Countermeasure Priority Review Voucher; FABHALTA
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Issuing agencies
Abstract
The Food and Drug Administration (FDA) is announcing the approval of a product redeeming a material threat medical countermeasure (MCM) priority review voucher. 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 issuance of material threat MCM priority review vouchers as well as the approval of products redeeming a voucher. FDA has determined that FABHALTA (iptacopan) capsules, approved December 5, 2023, meets the redemption criteria.
Full Text
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<title>Federal Register, Volume 89 Issue 10 (Tuesday, January 16, 2024)</title>
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[Federal Register Volume 89, Number 10 (Tuesday, January 16, 2024)]
[Notices]
[Page 2624]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-00688]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-0065]
Notice of Approval of Product Under Voucher: Material Threat
Medical Countermeasure Priority Review Voucher; FABHALTA
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
approval of a product redeeming a material threat medical
countermeasure (MCM) priority review voucher. 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 issuance of material threat MCM priority review vouchers
as well as the approval of products redeeming a voucher. FDA has
determined that FABHALTA (iptacopan) capsules, approved December 5,
2023, meets the redemption criteria.
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#ffbc9e8b978d8691d1b39a9abf999b9ed197978cd1989089"><span class="__cf_email__" data-cfemail="692a081d011b100747250c0c290f0d084701011a470e061f">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under section 565A of the FD&C Act (21
U.S.C. 360bbb-4a) FDA will report the issuance of material threat MCM
priority review vouchers and the approval of products for which a
voucher was redeemed. FDA has determined that the application for
FABHALTA (iptacopan) capsules, approved December 5, 2023, meets the
redemption criteria.
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
FABHALTA (iptacopan) capsules go to the ``Drugs@FDA'' website at <a href="http://www.accessdata.fda.gov/scripts/cder/daf/">http://www.accessdata.fda.gov/scripts/cder/daf/</a>.
Dated: January 10, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-00688 Filed 1-12-24; 8:45 am]
BILLING CODE 4164-01-P
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