80_FR_51440 80 FR 51277 - Use of Rare Pediatric Disease Priority Review Voucher; Approval of a Drug Product

80 FR 51277 - Use of Rare Pediatric Disease Priority Review Voucher; Approval of a Drug Product

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 163 (August 24, 2015)

Page Range51277-51277
FR Document2015-20833

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.

Federal Register, Volume 80 Issue 163 (Monday, August 24, 2015) 
[Federal Register Volume 80, Number 163 (Monday, August 24, 2015)]
[Notices]
[Page 51277]
From the Federal Register Online  [www.thefederalregister.org]
[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

Federal Register / Vol. 80, No. 163 / Monday, August 24, 2015 / Notices 51277 There are currently 15 active ADSSP ACTION: Notice. Dated: August 19, 2015. grantees engaged in the development of Leslie Kux, dementia-capable systems in their state SUMMARY: The Food and Drug Associate Commissioner for Policy. to support individuals with ADRD and Administration (FDA) is announcing the [FR Doc. 2015–20833 Filed 8–21–15; 8:45 am] their caregivers. ACL will provide recent approval of a drug product under an application for which the sponsor BILLING CODE 4164–01–P additional resources to support the expansion of promising program redeemed a rare pediatric disease activities under existing ADSSP projects priority review voucher. The Federal Food, Drug, and Cosmetic Act (the DEPARTMENT OF HEALTH AND in the states of Minnesota and Ohio. HUMAN SERVICES Both the Minnesota and Ohio grantees FD&C Act), as amended by the Food and are engaged in projects that are building Drug Administration Safety and Food and Drug Administration the dementia-capability of their state Innovation Act (FDASIA), authorizes systems that merit expansion. The state FDA to redeem priority review vouchers [Docket No. FDA–2015–N–2489] of Minnesota will expand on their submitted by sponsors of product applications that might otherwise not Receipt of Notice That a Patent existing program efforts to build strong Infringement Complaint Was Filed linkages between a Health Care Partner qualify for priority review. These vouchers entitle the holder of such a Against a Biosimilar Applicant (HCP) and Community Based Organizations (CBO). The state of Ohio voucher to priority review of a single AGENCY: Food and Drug Administration, will expand on their existing ADSSP human drug application submitted HHS. project goal to enrich the lives of under the FD&C Act or the Public Health Service Act. FDA has approved ACTION: Notice. veterans suffering from cognitive and physical challenges and their caregivers PRALUENT (alirocumab), manufactured SUMMARY: The Food and Drug by expanding Ohio’s Music & by Sanofi-Aventis U.S. Inc., under a Administration (FDA) is publishing MemorySM program living in their priority review. notice that an applicant for a proposed homes and communities. FOR FURTHER INFORMATION CONTACT: biosimilar product notified FDA that a Justification: ACL is committed to the Larry Bauer, Rare Diseases Program, patent infringement action was filed in success, continued expansion and Center for Drug Evaluation and connection with the applicant’s sustainability of ADSSP projects. Each Research, Food and Drug biologics license application (BLA). of the identified existing cooperative Administration, 10903 New Hampshire Under the Public Health Service Act agreement projects has components Ave., Silver Spring, MD 20993–0002, (PHS Act), an applicant for a proposed within them from which the 301–796–4842, FAX: 301–796–9858, biosimilar product or interchangeable communities that they serve will benefit email: larry.bauer@fda.hhs.gov. product must notify FDA within 30 days and merit uninterrupted expansion. To SUPPLEMENTARY INFORMATION: FDA is after the applicant was served with a ensure uninterrupted continuation announcing the recent approval of a complaint in a patent infringement toward achieving and exceeding their drug product under an application for action described under the PHS Act. goals and objectives and expansion of which the sponsor redeemed a rare FDA is required to publish notice of the program efforts, ACL plans to issue one- pediatric disease priority review complaint in the Federal Register. year non-competing awards to both the voucher. Under section 529 of the FD&C FOR FURTHER INFORMATION CONTACT: Minnesota Board on Aging and the Ohio Act (21 U.S.C. 360ff), added by FDASIA, Daniel Orr, Center for Drug Evaluation Department on Aging. FDA will grant a priority review for a and Research, Food and Drug new drug or biological product I. Agency Contact Administration, 10903 New Hampshire application that redeems a priority For further information or comments Ave., Bldg. 51, Rm. 6208, Silver Spring, review voucher, even if that product regarding this action, contact Erin Long, MD 20993–0002, 240–402–0979, might not otherwise qualify for a U.S. Department of Health and Human daniel.orr@fda.hhs.gov. priority review. FDA has recently Services, Administration for approved PRALUENT (alirocumab), SUPPLEMENTARY INFORMATION: The Community Living, Administration on manufactured by Sanofi-Aventis U.S. Biologics Price Competition and Aging, Washington, DC 20201; Inc., under a priority review. Innovation Act of 2009 (BPCI Act) was telephone (202) 357–3448; fax (202) PRALUENT (alirocumab) is indicated as enacted as part of the Patient Protection 357–3549; email Erin.Long@acl.hhs.gov. an adjunct to diet and maximally and Affordable Care Act (Pub. L. 111– Dated: August 11, 2015. tolerated statin therapy for the treatment 148) on March 23, 2010. The BPCI Act Kathy Greenlee, of adults with heterozygous familial amended the PHS Act and created an hypercholesterolemia or clinical abbreviated licensure pathway for Assistant Secretary for Aging. atherosclerotic cardiovascular disease, biological products shown to be [FR Doc. 2015–20796 Filed 8–21–15; 8:45 am] who require additional lowering of low- biosimilar to, or interchangeable with, BILLING CODE 4154–01–P density lipoprotein cholesterol. an FDA-licensed biological reference For further information about the Rare product. Section 351(k) of the PHS Act Pediatric Disease Priority Review (42 U.S.C. 262(k)), added by the BPCI DEPARTMENT OF HEALTH AND Voucher Program and for a link to the Act, describes the requirements for a HUMAN SERVICES full text of section 529 of the FD&C Act, BLA for a proposed biosimilar product Food and Drug Administration go to http://www.fda.gov/ForIndustry/ or a proposed interchangeable product DevelopingProductsforRareDiseases (351(k) BLA). Section 351(l) of the PHS [Docket No. FDA–2014–N–0229] tkelley on DSK3SPTVN1PROD with NOTICES Conditions/RarePediatricDiseasePriority Act, also added by the BPCI Act, VoucherProgram/default.htm. describes certain procedures for Use of Rare Pediatric Disease Priority For further information about exchanging patent information and Review Voucher; Approval of a Drug PRALUENT (alirocumab), go to the resolving patent disputes between a Product Drugs@FDA Web site at http:// 351(k) BLA applicant and the holder of AGENCY: Food and Drug Administration, www.accessdata.fda.gov/scripts/cder/ the BLA reference product. If a 351(k) HHS. drugsatfda/index.cfm. applicant is served with a complaint for VerDate Sep<11>2014 16:48 Aug 21, 2015 Jkt 235001 PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 E:\FR\FM\24AUN1.SGM 24AUN1


Document Created: 2015-12-15 10:54:31
Document Modified: 2015-12-15 10:54:31
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactLarry 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]
FR Citation80 FR 51277 
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