88 FR 51 pgs. 16274-16275 - Issuance of Priority Review Voucher; Rare Pediatric Disease Product
Type: NOTICEVolume: 88Number: 51Pages: 16274 - 16275
Pages: 16274, 16275Docket number: [Docket No. FDA-2020-N-0026]
FR document: [FR Doc. 2023-05355 Filed 3-15-23; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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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.
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), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), 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 LAMZEDE (velmanase alfa-tycv), approved February 16, 2023, and manufactured by Chiesi Farmaceutici S.p.A., 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, email: Cathryn.Lee@fda.hhs.gov.
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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), which was added by FDASIA, FDA will award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA has determined that LAMZEDE (velmanase alfa-tycv), manufactured by Chiesi Farmaceutici S.p.A., meets the criteria for a priority review voucher. LAMZEDE (velmanase alfa-tycv) injection is for the treatment of non-central nervous system manifestations of alpha-mannosidosis.
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 LAMZEDE (velmanase alfa-tycv), go to the " Drugs@FDA " website at http://www.accessdata.fda.gov/scripts/cder/daf/.
Dated: March 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-05355 Filed 3-15-23; 8:45 am]
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