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

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

Federal Register Volume 83, Number 69 (Tuesday, April 10, 2018)

Notices

Pages 15390-15391

From the Federal Register Online via the Government Publishing Office www.gpo.gov

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 ``email protected'' 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

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