Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product; EBANGA
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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 EBANGA (ansuvimab-zykl) for injection, approved on December 21, 2020, manufactured by Ridgeback Biotherapeutics, LP, meets the criteria for a material threat MCM priority review voucher.
Full Text
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<title>Federal Register, Volume 90 Issue 77 (Wednesday, April 23, 2025)</title>
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[Federal Register Volume 90, Number 77 (Wednesday, April 23, 2025)]
[Notices]
[Pages 17071-17072]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-06970]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0647]
Issuance of Priority Review Voucher; Material Threat Medical
Countermeasure Product; EBANGA
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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[[Page 17072]]
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 EBANGA (ansuvimab-zykl) for injection, approved on
December 21, 2020, manufactured by Ridgeback Biotherapeutics, LP, meets
the criteria for a material threat MCM priority review voucher.
FOR FURTHER INFORMATION CONTACT: Andrea Gormley, Counter-Terrorism and
Emergency Coordination Staff, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., 2nd Floor,
Silver Spring, MD 20993-0002, 301-796-2210 (this is not a toll free
number).
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 EBANGA (ansuvimab-zykl), manufactured by Ridgeback
Biotherapeutics, LP, meets the criteria for a material threat MCM
priority review voucher. EBANGA was approved on December 21, 2020, for
the treatment of infection caused by Zaire ebolavirus in adult and
pediatric patients, including neonates born to a mother who is RT-PCR
positive for Zaire ebolavirus infection.
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
EBANGA (ansuvimab-zykl) for injection, 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: April 16, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-06970 Filed 4-22-25; 8:45 am]
BILLING CODE 4164-01-P
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