87 FR 173 pg. 55011 - Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher
Type: NOTICEVolume: 87Number: 173Page: 55011
Page: 55011Docket number: [Docket No. FDA-2018-N-1262]
FR document: [FR Doc. 2022-19384 Filed 9-7-22; 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-2018-N-1262]
Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) is announcing the issuance of approval of product redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (the 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 issuance of priority review vouchers as well as the approval of products redeeming a priority review voucher. FDA has determined that VABYSMO (faricimab-svoa), for which a priority review voucher was redeemed, was approved January 28, 2022.
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.
SUPPLEMENTARY INFORMATION:
FDA is announcing the approval of product redeeming a rare pediatric disease priority review voucher. Under section 529 of the FD&C Act (21 U.S.C. 360ff), which was added by FDASIA, 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 VABYSMO (faricimab-svoa), approved January 28, 2022, 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 VABYSMO (faricimab-svoa), go to the "Drugs@FDA" website at https://www.accessdata.fda.gov/scripts/cder/daf/.
Dated: August 31, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-19384 Filed 9-7-22; 8:45 am]
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