Issuance of Priority Review Voucher; Rare Pediatric Disease Product
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Issuing agencies
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 232 (Tuesday, December 5, 2023)</title>
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[Federal Register Volume 88, Number 232 (Tuesday, December 5, 2023)]
[Notices]
[Page 84337]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm">http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm</a>. For further
information about XENPOZYME (olipudase alfa-rpcp), go to the
``Drugs@FDA'' website at <a href="http://www.accessdata.fda.gov/scripts/cder/daf/">http://www.accessdata.fda.gov/scripts/cder/daf/</a>.
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
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