Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ZYCUBO (Copper Histidinate)
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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 rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that ZYCUBO (copper histidinate), approved January 12, 2026, manufactured by Sentynl Therapeutics Inc., meets the criteria for a priority review voucher.
Full Text
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<title>Federal Register, Volume 91 Issue 39 (Friday, February 27, 2026)</title>
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[Federal Register Volume 91, Number 39 (Friday, February 27, 2026)]
[Notices]
[Pages 9864-9865]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-03925]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-1486]
Issuance of Priority Review Voucher; Rare Pediatric Disease
Product; ZYCUBO (Copper Histidinate)
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 rare
pediatric disease product application. The Federal Food, Drug, and
Cosmetic Act (FD&C Act) authorizes FDA to award priority review
vouchers to sponsors of approved rare pediatric disease product
applications that meet certain criteria. FDA is required to publish
notice of the award of the priority review voucher. FDA has determined
that ZYCUBO (copper histidinate), approved January 12, 2026,
manufactured by Sentynl Therapeutics Inc., meets the criteria for a
priority review voucher.
[[Page 9865]]
FOR FURTHER INFORMATION CONTACT: Quyen Tran, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Room 5324, Silver Spring, MD 20993-0002, 301-796-2771,
<a href="/cdn-cgi/l/email-protection#bdecc8c4d8d393e9cfdcd38cfddbd9dc93d5d5ce93dad2cb"><span class="__cf_email__" data-cfemail="faab8f839f94d4ae889b94cbba9c9e9bd4929289d49d958c">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: FDA is announcing the issuance of a priority
review voucher to the sponsor of an approved rare pediatric disease
product application. Under section 529 of the FD&C Act (21 U.S.C.
360ff), FDA will award priority review vouchers to sponsors of approved
rare pediatric disease product applications that meet certain criteria.
FDA has determined ZYCUBO (copper histidinate), manufactured by Sentynl
Therapeutics Inc., meets the criteria for a priority review voucher.
ZYCUBO (copper histidinate) injection is indicated for treatment of
Menkes disease in pediatric patients.
For further information about the Rare Pediatric Disease Priority
Review Voucher Program and for a link to the full text of section 529
of the FD&C Act, go to <a href="https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm">https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm</a>. For further
information about ZYCUBO (copper histidinate), 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>.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-03925 Filed 2-26-26; 8:45 am]
BILLING CODE 4164-01-P
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