[Federal Register Volume 89, Number 15 (Tuesday, January 23, 2024)]
[Notices]
[Pages 4314-4315]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-01156]


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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

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 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 XYWAV (calcium, magnesium, potassium, 
and sodium oxybates), approved July 21, 2020, 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 XYWAV (calcium, magnesium, potassium, and sodium 
oxybates) meets the redemption criteria.

[[Page 4315]]

    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 XYWAV (calcium, magnesium, potassium, and sodium 
oxybates), go to the ``Drugs@FDA'' website at https://www.accessdata.fda.gov/scripts/cder/daf/.

    Dated: January 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-01156 Filed 1-22-24; 8:45 am]
BILLING CODE 4164-01-P