Issuance of Priority Review Voucher; Rare Pediatric Disease Product, 19052 [2017-08309]
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19052
Federal Register / Vol. 82, No. 78 / Tuesday, April 25, 2017 / Notices
Food and Drug Administration
Dated: April 19, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[Docket No. FDA–2017–N–0809]
[FR Doc. 2017–08309 Filed 4–24–17; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4164–01–P
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
Food and Drug Administration
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
approved rare pediatric disease product
applications that meet certain criteria.
FDA is required to publish notice of the
award of the priority review voucher.
FDA has determined that EMFLAZA
(deflazacort) oral tablets, and oral
suspension manufactured by Marathon
Pharmaceuticals, LLC, meets the criteria
for a priority review voucher.
FOR FURTHER INFORMATION CONTACT:
Larry Bauer, 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: larry.bauer@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
announcing the issuance of a priority
review voucher to the sponsor of an
approved 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
approved rare pediatric disease product
applications that meet certain criteria.
FDA has determined that Emflaza
(deflazacort) manufactured by Marathon
Pharmaceuticals, LLC, meets the criteria
for a priority review voucher.
EMFLAZA (deflazacort) is indicated for
the treatment of Duchenne Muscular
Dystrophy in patients 5 years of age and
older.
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 EMFLAZA
(deflazacort), go to the ‘‘Drugs@FDA’’
Web site at https://www.accessdata.
fda.gov/scripts/cder/daf/.
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SUMMARY:
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17:42 Apr 24, 2017
DEPARTMENT OF HEALTH AND
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Agency Information Collection
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[Federal Register Volume 82, Number 78 (Tuesday, April 25, 2017)]
[Notices]
[Page 19052]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-08309]
[[Page 19052]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-0809]
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 approved rare pediatric disease product
applications that meet certain criteria. FDA is required to publish
notice of the award of the priority review voucher. FDA has determined
that EMFLAZA (deflazacort) oral tablets, and oral suspension
manufactured by Marathon Pharmaceuticals, LLC, meets the criteria for a
priority review voucher.
FOR FURTHER INFORMATION CONTACT: Larry Bauer, 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: larry.bauer@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is announcing the issuance of a priority
review voucher to the sponsor of an approved 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 approved rare pediatric disease product
applications that meet certain criteria. FDA has determined that
Emflaza (deflazacort) manufactured by Marathon Pharmaceuticals, LLC,
meets the criteria for a priority review voucher. EMFLAZA (deflazacort)
is indicated for the treatment of Duchenne Muscular Dystrophy in
patients 5 years of age and older.
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 EMFLAZA (deflazacort), go to the ``Drugs@FDA'' Web
site at https://www.accessdata.fda.gov/scripts/cder/daf/.
Dated: April 19, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-08309 Filed 4-24-17; 8:45 am]
BILLING CODE 4164-01-P
