Document ID: FDA-2018-N-1262-0004
Agency: fda
Document Type: Notice
Title: Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher
Posted Date: 2019-05-03T04:00Z

[Federal Register Volume 84, Number 86 (Friday, May 3, 2019)]
[Notices]
[Pages 19085-19086]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-09005]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Notice of 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 ULTOMIRIS (ravulizumab-cwvz) approved December 21, 
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: althea.cuff@fda.hhs.gov.

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 ULTOMIRIS 
(ravulizumab-cwvz) approved December 21, 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 ULTOMIRIS (ravulizumab-cwvz) go to the ``[email protected]'' 
website at https://

[[Page 19086]]

www.accessdata.fda.gov/scripts/cder/daf/.

    Dated: April 29, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-09005 Filed 5-2-19; 8:45 am]
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