[Federal Register Volume 89, Number 10 (Tuesday, January 16, 2024)]
[Notices]
[Page 2624]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: 
[email protected].

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 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 
FABHALTA (iptacopan) capsules go to the ``Drugs@FDA'' website at http://www.accessdata.fda.gov/scripts/cder/daf/.

    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