Document ID: FDA-2014-N-0229-0002
Agency: fda
Document Type: Notice
Title: Issuance of Priority Review Voucher; Rare Pediatric Disease Product
Posted Date: 2015-04-07T04:00Z

[Federal Register Volume 80, Number 66 (Tuesday, April 7, 2015)]
[Notices]
[Pages 18628-18629]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-08014]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0229]

Issuance of Priority Review Voucher; Rare Pediatric Disease 
Product

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 (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 rare pediatric disease 
product applications that meet certain criteria. FDA has determined 
that UNITUXIN (dinutuximab), manufactured by United Therapeutics 
Corporation, meets the criteria for a priority review voucher.

[[Page 18629]]

FOR FURTHER INFORMATION CONTACT: Larry Bauer, Rare Diseases Program, 
Center for Drug Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-4842, 
FAX: 301-796-9858, email: larry.bauer@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: FDA is announcing the issuance of a priority 
review voucher to the sponsor of a rare pediatric disease product 
application. Under section 529 of the FD&C Act (21 U.S.C. 360ff), added 
by FDASIA, FDA will award priority review vouchers to sponsors of rare 
pediatric disease product applications that meet certain criteria. FDA 
has determined that UNITUXIN (dinutuximab), manufactured by United 
Therapeutics Corporation, meets the criteria for a priority review 
voucher. UNITUXIN (dinutuximab) is indicated, in combination with 
granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-
2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric 
patients with high-risk neuroblastoma who achieve at least a partial 
response to prior first-line multiagent, multimodality therapy. 
Neuroblastoma is the most common pediatric solid tumor occurring 
outside the brain, and it is the most common cancer in infants.
    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 UNITUXIN (dinutuximab), go to the 
Drugs@FDA Web site at http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm.

    Dated: April 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-08014 Filed 4-6-15; 8:45 am]
BILLING CODE CODE 4164-01-P