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