[Federal Register Volume 89, Number 137 (Wednesday, July 17, 2024)]
[Notices]
[Pages 58165-58166]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-15695]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1262]


Notice of Approval of Product Under Voucher: Rare Pediatric 
Disease Priority Review Voucher; VYVGART HYTRULO (efgartigimod alfa and 
hyaluronidase-qvfc)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
issuance of approval of a product redeeming a priority review voucher. 
The Federal Food, Drug, and Cosmetic

[[Page 58166]]

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 
issuance of priority review vouchers as well as the approval of 
products redeeming a priority review voucher. FDA has determined that 
the supplemental application (Supplement-5) for VYVGART HYTRULO 
(efgartigimod alfa and hyaluronidase-qvfc), approved June 21, 2024, 
meets the criteria for redeeming a priority review voucher.

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: FDA is announcing the approval of a product 
redeeming a rare pediatric disease priority review voucher. Under 
section 529 of the FD&C Act (21 U.S.C. 360ff), FDA will report the 
issuance of rare pediatric disease priority review vouchers and the 
approval of products for which a voucher was redeemed. FDA has 
determined that the supplemental application (Supplement-5) for VYVGART 
HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) meets the redemption 
criteria.
    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 VYVGART HYTRULO (efgartigimod alfa and hyaluronidase-
qvfc), go to the ``Drugs@FDA'' website at https://www.accessdata.fda.gov/scripts/cder/daf/.

    Dated: July 11, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-15695 Filed 7-16-24; 8:45 am]
BILLING CODE 4164-01-P