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Home » 2018 Issues » 83 FR (04/10/2018) » 2018-07256. Notice of Approval of Products Under Voucher: Rare Pediatric Disease Priority Review Vouchers

  2018-07256. Notice of Approval of Products Under Voucher: Rare Pediatric Disease Priority Review Vouchers  

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    AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    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.

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    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: althea.cuff@fda.hhs.gov.

    End Further Info End Preamble Start Supplemental Information

    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/​.

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    Dated: April 4, 2018.

    Leslie Kux,

    Associate Commissioner for Policy.

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    [FR Doc. 2018-07256 Filed 4-9-18; 8:45 am]

    BILLING CODE 4164-01-P

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Document Information

Published:
04/10/2018
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice.
Document Number:
2018-07256
Pages:
15390-15391 (2 pages)
Docket Numbers:
Docket No. FDA-2018-N-1262
PDF File:
2018-07256.pdf
Supporting Documents:
» Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher
» Issuance of Priority Review Voucher; Rare Pediatric Disease Product
» Issuance of Priority Review Voucher; Rare Pediatric Disease Product
» Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher
» Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher
» Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher
» Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher
» Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher
» Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher
» Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher