83 FR 69 pgs. 15390-15391 - Notice of Approval of Products Under Voucher: Rare Pediatric Disease Priority Review Vouchers
Type: NOTICEVolume: 83Number: 69Pages: 15390 - 15391
Pages: 15390, 15391Docket number: [Docket No. FDA-2018-N-1262]
FR document: [FR Doc. 2018-07256 Filed 4-9-18; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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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.
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.
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]
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