83 FR 53880 - Issuance of Priority Review Voucher; Rare Pediatric Disease Product

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 207 (October 25, 2018)

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 REVCOVI (elapegademase-lvlr) Injection, manufactured by Leadiant Bioscience Inc., meets the criteria for a priority review voucher.

[Federal Register Volume 83, Number 207 (Thursday, October 25, 2018)]
[Notices]
[Page 53880]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-23308]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1262]


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 (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 REVCOVI (elapegademase-lvlr) Injection, manufactured by Leadiant 
Bioscience Inc., 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: [email protected].

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 
REVCOVI (elapegademase-lvlr) Injection, manufactured by Leadiant 
Bioscience Inc., meets the criteria for a priority review voucher. 
REVCOVI (elapegademase-lvlr) Injection is indicated for the treatment 
of Adenosine Deaminase-Severe Combined Immunodeficiency (ADA-SCID) in 
pediatric and adult patients.
    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 REVCOVI (elapegademase-lvlr) Injection, go to the 
``[email protected]'' website at https://www.accessdata.fda.gov/scripts/cder/daf/.

    Dated: October 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23308 Filed 10-24-18; 8:45 am]
 BILLING CODE 4164-01-P