80 FR 58489 - Issuance of Priority Review Voucher; Rare Pediatric Disease Product
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 188 (September 29, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 188 (September 29, 2015)
| Page Range | 58489-58489 | |
| FR Document | 2015-24640 |
[Federal Register Volume 80, Number 188 (Tuesday, September 29, 2015)] [Notices] [Page 58489] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-24640] ----------------------------------------------------------------------- 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, [email protected]. 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 http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm. For further information about Xuriden (uridine triacetate), go to the Drugs@FDA Web site at http://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
![Federal Register / Vol. 80, No. 188 / Tuesday, September 29, 2015 / Notices 58489
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 Approval date
P140017, FDA–2015–M–0266 ................. Medtronic, Inc. ........................................ MelodyTM Transcatheter Pulmonary 1/27/2015
Valve (TPV) and EnsembleTM
Transcatheter Valve Delivery System.
P130023, FDA–2015–M–0431 ................. Cohera Medical, Inc. ............................... TissuGlu® Surgical Adhesive .................. 2/3/2015
P010047/S036, FDA–2015–M–0502 ........ NeoMend, Inc. ......................................... ProGelTM Pleural Air Leak Sealant ........ 2/13/2015
P140018, FDA–2015–M–0690 ................. Covidien, LLC ......................................... VenaSealTM Closure System .................. 2/20/2015
H130001, FDA–2015–M–0909 ................. Biologics Consulting Group, Inc. ............ Lixelle Beta 2-microglobulin Apheresis 3/5/2015
Column.
P110024, FDA–2015–M–0738 ................. Advanced Circulatory Systems, Inc. ....... ResQCPRTM System .............................. 3/6/2015
P130013, FDA–2015–M–0910 ................. Boston Scientific Corp. ........................... WATCHMANTM Left Atrial Appendage 3/13/2015
(LAA) Closure Technology.
II. Electronic Access SUPPLEMENTARY INFORMATION: FDA is DEPARTMENT OF HEALTH AND
Persons with access to the Internet announcing the issuance of a priority HUMAN SERVICES
may obtain the documents at http:// review voucher to the sponsor of a rare
www.fda.gov/MedicalDevices/ pediatric disease product application. Food and Drug Administration
ProductsandMedicalProcedures/ Under section 529 of the FD&C Act (21 [Docket No. FDA–2015–N–3393]
DeviceApprovalsandClearances/ U.S.C. 360ff), which was added by
PMAApprovals/default.htm. FDASIA, FDA will award priority Determination That ORTHO EVRA
Dated: September 23, 2015. review vouchers to sponsors of rare (Norelgestromin/Ethinyl Estradiol)
pediatric disease product applications Transdermal System, 0.15 Milligrams/
Leslie Kux,
that meet certain criteria. FDA has 24 Hours Norelgestromin and 0.035
Associate Commissioner for Policy.
determined that Xuriden (uridine Milligrams/24 Hours Ethinyl Estradiol,
[FR Doc. 2015–24625 Filed 9–28–15; 8:45 am] Was Not Withdrawn From Sale for
BILLING CODE 4164–01–P
triacetate), manufactured by Wellstat
Therapeutics Corp., meets the criteria Reasons of Safety or Effectiveness
for a priority review voucher. Uridine AGENCY: Food and Drug Administration,
DEPARTMENT OF HEALTH AND triacetate is a pyrimidine analog for HHS.
HUMAN SERVICES uridine replacement. Xuriden is ACTION: Notice.
indicated for the treatment of hereditary
Food and Drug Administration orotic aciduria. Hereditary orotic SUMMARY: The Food and Drug
[Docket No. FDA–2014–N–0229] aciduria is caused by a deficiency in the Administration (FDA or Agency) has
activity of the pyrimidine pathway determined that ORTHO EVRA
Issuance of Priority Review Voucher; enzyme uridine 5′-monophosphate (norelgestromin/ethinyl estradiol)
Rare Pediatric Disease Product synthase. The disorder is generally Transdermal System, 0.15 milligrams
characterized by anemia and/or other (mg)/24 hours (hr) norelgestromin and
AGENCY: Food and Drug Administration,
hematological manifestations, excessive 0.035 mg/24hr ethinyl estradiol was not
HHS.
urinary excretion of orotic acid, failure withdrawn from sale for reasons of
ACTION: Notice. safety or effectiveness. This
to thrive, and developmental delay.
SUMMARY: The Food and Drug determination means that FDA will not
For further information about the Rare begin procedures to withdraw approval
Administration (FDA) is announcing the Pediatric Disease Priority Review
issuance of a priority review voucher to of abbreviated new drug applications
Voucher Program and for a link to the (ANDAs) that refer to this drug product,
the sponsor of a rare pediatric disease
full text of section 529 of the FD&C Act, and it will allow FDA to continue to
product application. The Federal Food,
go to http://www.fda.gov/ForIndustry/ approve ANDAs that refer to the
Drug, and Cosmetic Act (FD&C Act), as
amended by the Food and Drug DevelopingProductsforRareDiseases product as long as they meet relevant
Administration Safety and Innovation Conditions/RarePediatricDiseasePriority legal and regulatory requirements.
Act (FDASIA), authorizes FDA to award VoucherProgram/default.htm. FOR FURTHER INFORMATION CONTACT:
priority review vouchers to sponsors of For further information about Xuriden Ayako Sato, Center for Drug Evaluation
rare pediatric disease product (uridine triacetate), go to the Drugs@ and Research, Food and Drug
applications that meet certain criteria. FDA Web site at http://www.accessdata. Administration, 10903 New Hampshire
FDA has determined that Xuriden fda.gov/scripts/cder/drugsatfda/ Ave., Bldg. 51, Rm. 6206, Silver Spring,
(uridine triacetate), manufactured by index.cfm. MD 20993–0002, 240–402–4191,
Wellstat Therapeutics Corp., meets the Ayako.Sato@fda.hhs.gov.
Dated: September 24, 2015.
criteria for a priority review voucher. SUPPLEMENTARY INFORMATION: In 1984,
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Leslie Kux,
FOR FURTHER INFORMATION CONTACT: Congress enacted the Drug Price
Larry Bauer, Rare Diseases Program, Associate Commissioner for Policy. Competition and Patent Term
Center for Drug Evaluation and [FR Doc. 2015–24640 Filed 9–28–15; 8:45 am] Restoration Act of 1984 (Public Law 98–
Research, Food and Drug BILLING CODE 4164–01–P 417) (the 1984 amendments), which
Administration, 10903 New Hampshire authorized the approval of duplicate
Ave., Silver Spring, MD 20993–0002, versions of drug products approved
301–796–4842, FAX: 301–796–9858, under an ANDA procedure. ANDA
larry.bauer@fda.hhs.gov. applicants must, with certain
VerDate Sep<11>2014 17:54 Sep 28, 2015 Jkt 235001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\FR\FM\29SEN1.SGM 29SEN1](https://thefederalregister.org/doc/80_FR_58677/page/1.svg)
Document Created: 2015-12-15 09:47:23
Document Modified: 2015-12-15 09:47:23
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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 protected] | |
| FR Citation | 80 FR 58489 |
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