[Federal Register Volume 88, Number 232 (Tuesday, December 5, 2023)]
[Notices]
[Page 84337]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-26652]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0026]


Issuance of Priority Review Voucher; Rare Pediatric Disease 
Product

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 priority review voucher. FDA has determined that 
XENPOZYME (olipudase alfa-rpcp), manufactured by Genzyme Corporation, 
meets the criteria for 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.

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 that XENPOZYME (olipudase alfa-rpcp), manufactured 
by Genzyme Corporation, meets the criteria for a priority review 
voucher. XENPOZYME (olipudase alfa-rpcp) is indicated for treatment of 
non-central nervous system manifestations of acid sphingomyelinase 
deficiency (ASMD) in adult and 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 http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm. For further 
information about XENPOZYME (olipudase alfa-rpcp), go to the 
``Drugs@FDA'' website at http://www.accessdata.fda.gov/scripts/cder/daf/.

    Dated: November 30, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26652 Filed 12-4-23; 8:45 am]
BILLING CODE 4164-01-P