[Federal Register Volume 80, Number 163 (Monday, August 24, 2015)]
[Notices]
[Page 51277]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20833]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0229]
Use of Rare Pediatric Disease Priority Review Voucher; Approval
of a Drug Product
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
recent approval of a drug product under an application for which the
sponsor redeemed a rare pediatric disease priority review voucher. The
Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the
Food and Drug Administration Safety and Innovation Act (FDASIA),
authorizes FDA to redeem priority review vouchers submitted by sponsors
of product applications that might otherwise not qualify for priority
review. These vouchers entitle the holder of such a voucher to priority
review of a single human drug application submitted under the FD&C Act
or the Public Health Service Act. FDA has approved PRALUENT
(alirocumab), manufactured by Sanofi-Aventis U.S. Inc., under a
priority review.
FOR FURTHER INFORMATION CONTACT: Larry Bauer, Rare Diseases Program,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-4842,
FAX: 301-796-9858, email: [email protected].
SUPPLEMENTARY INFORMATION: FDA is announcing the recent approval of a
drug product under an application for which the sponsor redeemed a rare
pediatric disease priority review voucher. Under section 529 of the
FD&C Act (21 U.S.C. 360ff), added by FDASIA, FDA will grant a priority
review for a new drug or biological product application that redeems a
priority review voucher, even if that product might not otherwise
qualify for a priority review. FDA has recently approved PRALUENT
(alirocumab), manufactured by Sanofi-Aventis U.S. Inc., under a
priority review. PRALUENT (alirocumab) is indicated as an adjunct to
diet and maximally tolerated statin therapy for the treatment of adults
with heterozygous familial hypercholesterolemia or clinical
atherosclerotic cardiovascular disease, who require additional lowering
of low-density lipoprotein cholesterol.
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 http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm.
For further information about PRALUENT (alirocumab), go to the
Drugs@FDA Web site at http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm.
Dated: August 19, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-20833 Filed 8-21-15; 8:45 am]
BILLING CODE 4164-01-P