83 FR 59386 - Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 226 (November 23, 2018)

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 vouchers as well as the approval of products redeeming a voucher. FDA has determined that AJOVY (fremanezumab-vfrm), approved September 14, 2018, meets the redemption criteria.

[Federal Register Volume 83, Number 226 (Friday, November 23, 2018)]
[Notices]
[Page 59386]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-25480]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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 vouchers 
as well as the approval of products redeeming a voucher. FDA has 
determined that AJOVY (fremanezumab-vfrm), approved September 14, 2018, 
meets the redemption criteria.

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-
796-9858, email: [email protected].

SUPPLEMENTARY INFORMATION: 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 AJOVY 
(fremanezumab-vfrm), approved September 14, 2018, 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 AJOVY (fremanezumab-vfrm) go to the ``Drugs@FDA'' 
website at https://www.accessdata.fda.gov/scripts/cder/daf/.

    Dated: November 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-25480 Filed 11-21-18; 8:45 am]
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