Issuance of Priority Review Voucher; Rare Pediatric Disease Product, 58489 [2015-24640]

Download as PDF 58489 Federal Register / Vol. 80, No. 188 / Tuesday, September 29, 2015 / Notices TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JANUARY 1, 2015, THROUGH MARCH 31, 2015—Continued PMA No., Docket No. Applicant Trade name P140017, FDA–2015–M–0266 ................. Medtronic, Inc. ........................................ P130023, FDA–2015–M–0431 ................. P010047/S036, FDA–2015–M–0502 ........ P140018, FDA–2015–M–0690 ................. H130001, FDA–2015–M–0909 ................. Cohera Medical, Inc. ............................... NeoMend, Inc. ......................................... Covidien, LLC ......................................... Biologics Consulting Group, Inc. ............ P110024, FDA–2015–M–0738 ................. P130013, FDA–2015–M–0910 ................. Advanced Circulatory Systems, Inc. ....... Boston Scientific Corp. ........................... MelodyTM Transcatheter Pulmonary Valve (TPV) and EnsembleTM Transcatheter Valve Delivery System. TissuGlu® Surgical Adhesive .................. ProGelTM Pleural Air Leak Sealant ........ VenaSealTM Closure System .................. Lixelle Beta 2-microglobulin Apheresis Column. ResQCPRTM System .............................. WATCHMANTM Left Atrial Appendage (LAA) Closure Technology. II. Electronic Access Persons with access to the Internet may obtain the documents at https:// www.fda.gov/MedicalDevices/ ProductsandMedicalProcedures/ DeviceApprovalsandClearances/ PMAApprovals/default.htm. Dated: September 23, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–24625 Filed 9–28–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0229] Issuance of Priority Review Voucher; Rare Pediatric Disease Product AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. 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 rare pediatric disease product applications that meet certain criteria. FDA has determined that Xuriden (uridine triacetate), manufactured by Wellstat Therapeutics Corp., meets the criteria for a priority review voucher. 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, larry.bauer@fda.hhs.gov. asabaliauskas on DSK5VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:54 Sep 28, 2015 Jkt 235001 FDA is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. Under section 529 of the FD&C Act (21 U.S.C. 360ff), which was added by FDASIA, FDA will award priority review vouchers to sponsors of rare pediatric disease product applications that meet certain criteria. FDA has determined that Xuriden (uridine triacetate), manufactured by Wellstat Therapeutics Corp., meets the criteria for a priority review voucher. Uridine triacetate is a pyrimidine analog for uridine replacement. Xuriden is indicated for the treatment of hereditary orotic aciduria. Hereditary orotic aciduria is caused by a deficiency in the activity of the pyrimidine pathway enzyme uridine 5′-monophosphate synthase. The disorder is generally characterized by anemia and/or other hematological manifestations, excessive urinary excretion of orotic acid, failure to thrive, and developmental delay. 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/ DevelopingProductsforRareDiseases Conditions/RarePediatricDiseasePriority VoucherProgram/default.htm. For further information about Xuriden (uridine triacetate), go to the Drugs@ FDA Web site at https://www.accessdata. fda.gov/scripts/cder/drugsatfda/ index.cfm. SUPPLEMENTARY INFORMATION: Dated: September 24, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–24640 Filed 9–28–15; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 Approval date 1/27/2015 2/3/2015 2/13/2015 2/20/2015 3/5/2015 3/6/2015 3/13/2015 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–3393] Determination That ORTHO EVRA (Norelgestromin/Ethinyl Estradiol) Transdermal System, 0.15 Milligrams/ 24 Hours Norelgestromin and 0.035 Milligrams/24 Hours Ethinyl Estradiol, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) has determined that ORTHO EVRA (norelgestromin/ethinyl estradiol) Transdermal System, 0.15 milligrams (mg)/24 hours (hr) norelgestromin and 0.035 mg/24hr ethinyl estradiol was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements. FOR FURTHER INFORMATION CONTACT: Ayako Sato, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6206, Silver Spring, MD 20993–0002, 240–402–4191, Ayako.Sato@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98– 417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA applicants must, with certain SUMMARY: E:\FR\FM\29SEN1.SGM 29SEN1

Agencies

[Federal Register Volume 80, Number 188 (Tuesday, September 29, 2015)]
[Notices]
[Page 58489]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24640]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0229]


Issuance of Priority Review Voucher; Rare Pediatric Disease 
Product

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
issuance of a priority review voucher to the sponsor of a rare 
pediatric disease product application. 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 rare pediatric disease product 
applications that meet certain criteria. FDA has determined that 
Xuriden (uridine triacetate), manufactured by Wellstat Therapeutics 
Corp., meets the criteria for a priority review voucher.

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, larry.bauer@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: FDA is announcing the issuance of a priority 
review voucher to the sponsor of a rare pediatric disease product 
application. Under section 529 of the FD&C Act (21 U.S.C. 360ff), which 
was added by FDASIA, FDA will award priority review vouchers to 
sponsors of rare pediatric disease product applications that meet 
certain criteria. FDA has determined that Xuriden (uridine triacetate), 
manufactured by Wellstat Therapeutics Corp., meets the criteria for a 
priority review voucher. Uridine triacetate is a pyrimidine analog for 
uridine replacement. Xuriden is indicated for the treatment of 
hereditary orotic aciduria. Hereditary orotic aciduria is caused by a 
deficiency in the activity of the pyrimidine pathway enzyme uridine 5'-
monophosphate synthase. The disorder is generally characterized by 
anemia and/or other hematological manifestations, excessive urinary 
excretion of orotic acid, failure to thrive, and developmental delay.
    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 Xuriden (uridine triacetate), go to 
the Drugs@FDA Web site at https://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm.

    Dated: September 24, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-24640 Filed 9-28-15; 8:45 am]
 BILLING CODE 4164-01-P
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