[Federal Register Volume 85, Number 235 (Monday, December 7, 2020)]
[Notices]
[Page 78859]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26801]


-----------------------------------------------------------------------

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 DANYELZA (naxitamab-gqgk) manufactured by Y-mAbs Therapeutics, 
Inc., (Cato Research LLC., US Agent) meets the criteria for a priority 
review voucher.

FOR FURTHER INFORMATION CONTACT: Althea Cuff, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-4061, FAX: 301-
796-9856, email: althea.cuff@fda.hhs.gov.

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 
DANYELZA (naxitamab-gqgk) manufactured by Y-mAbs Therapeutics, Inc., 
(Cato Research LLC., US Agent), meets the criteria for a priority 
review voucher.
    DANYELZA (naxitamab-gqgk) indicated, in combination with 
granulocyte-macrophage colony-stimulating factor (GM-CSF), for the 
treatment of pediatric patients 1 year of age and older and adult 
patients with relapsed or refractory high-risk neuroblastoma in the 
bone or bone marrow who have demonstrated a partial response, minor 
response, or stable disease to prior therapy.
    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 DANYELZA (naxitamab) go to the ``[email protected]'' website 
at http://www.accessdata.fda.gov/scripts/cder/daf/.

    Dated: December 1, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-26801 Filed 12-4-20; 8:45 am]
BILLING CODE 4164-01-P


