[Federal Register Volume 89, Number 95 (Wednesday, May 15, 2024)]
[Notices]
[Page 42472]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-10583]


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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; OJEMDA (tovorafenib)

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 the priority review voucher. FDA has determined 
that OJEMDA (tovorafenib), approved on April 23, 2024, manufactured by 
Day One Biopharmaceuticals, Inc., 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 OJEMDA (tovorafenib), manufactured by Day One 
Biopharmaceuticals, Inc., meets the criteria for a priority review 
voucher. OJEMDA (tovorafenib) is indicated for the treatment of 
patients 6 months of age and older with relapsed or refractory 
pediatric low-grade glioma harboring a BRAF fusion or rearrangement, or 
BRAF V600 mutation.
    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 OJEMDA (tovorafenib), go to the ``Drugs@FDA'' website 
at http://www.accessdata.fda.gov/scripts/cder/daf/.

    Dated: May 9, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-10583 Filed 5-14-24; 8:45 am]
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