[Federal Register Volume 87, Number 234 (Wednesday, December 7, 2022)]
[Notices]
[Page 75052]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-26565]


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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), 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 IMJUDO (tremelimumab), 
approved October 23, 2022, 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), 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 IMJUDO (tremelimumab), approved 
October 23, 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 IMJUDO (tremelimumab), approved October 23, 2022, go 
to the ``[email protected]'' website at https://www.accessdata.fda.gov/scripts/cder/daf/.

    Dated: December 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-26565 Filed 12-6-22; 8:45 am]
BILLING CODE 4164-01-P


