[Federal Register Volume 90, Number 242 (Friday, December 19, 2025)]
[Notices]
[Page 59530]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-23409]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2025-N-4683]


Issuance of Priority Review Voucher; Rare Pediatric Disease 
Product; FORZINITY (Elamipretide)

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 FORZINITY (elamipretide), approved September 19, 2025, 
manufactured by Stealth BioTherapeutics Inc., meets the criteria for a 
priority review voucher.

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, 
[email protected].

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 FORZINITY (elamipretide) manufactured by Stealth 
BioTherapeutics Inc., meets the criteria for a priority review voucher. 
FORZINITY (elamipretide) injection is indicated to improve muscle 
strength in adult and pediatric patients with Barth syndrome weighing 
at least 30 kg.
    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 https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm. For further 
information about FORZINITY (elamipretide), go to the ``Drugs@FDA'' 
website at https://www.accessdata.fda.gov/scripts/cder/daf/.

Lowell M. Zeta,
Acting Deputy Commissioner for Policy, Legislation, and International 
Affairs.
[FR Doc. 2025-23409 Filed 12-18-25; 8:45 am]
BILLING CODE 4164-01-P