83 FR 15390 - Notice of Approval of Products Under Voucher: Rare Pediatric Disease Priority Review Vouchers

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 69 (April 10, 2018)

The Food and Drug Administration (FDA) is announcing the issuance of several approvals of products 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.

[Federal Register Volume 83, Number 69 (Tuesday, April 10, 2018)]
[Notices]
[Pages 15390-15391]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-07256]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Notice of Approval of Products Under Voucher: Rare Pediatric 
Disease Priority Review Vouchers

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
issuance of several approvals of products 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.

[[Page 15391]]


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: 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 the following approved drugs meet the 
redemption criteria:
     PRALUENT (alirocumab) approved July 24, 2015,
     SOLIQUA (insulin glargine and lixisenatide) approved 
November 21, 2016, and
     JULUCA (dolutegravir and rilpivirine) approved November 
21, 2017.
    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 PRALUENT (alirocumab), SOLIQUA (insulin glargine and 
lixisenatide), and JULUCA (dolutegravir and rilpivirine), go to the 
``Drugs@FDA'' website at https://www.accessdata.fda.gov/scripts/cder/daf/.

    Dated: April 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07256 Filed 4-9-18; 8:45 am]
BILLING CODE 4164-01-P