[Federal Register Volume 91, Number 62 (Wednesday, April 1, 2026)]
[Notices]
[Page 16204]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-06316]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2026-N-3004]


Issuance of Priority Review Voucher; Rare Pediatric Disease 
Product; YUVIWEL (navepegritide)

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 YUVIWEL (navepegritide), approved February 27, 2026, manufactured 
by Ascendis Pharma Growth Disorders (A/S), 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 YUVIWEL (navepegritide), manufactured by Ascendis 
Pharma Growth Disorders (A/S), meets the criteria for a priority review 
voucher. YUVIWEL (navepegritide) injection is indicated to increase 
linear growth in pediatric patients 2 years of age and older with 
achondroplasia with open epiphyses.
    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 YUVIWEL (navepegritide), go to the ``Drugs@FDA'' 
website at https://www.accessdata.fda.gov/scripts/cder/daf/.

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-06316 Filed 3-31-26; 8:45 am]
BILLING CODE 4164-01-P