Issuance of Priority Review Voucher; Rare Pediatric Disease Product, 9514 [2021-03012]
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9514
Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices
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Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: February 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–03066 Filed 2–12–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0026]
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product
AGENCY:
Food and Drug Administration,
lower urinary oxalate levels in pediatric
and adult patients.
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 OXLUMO
(lumasiran) injection, go to the ‘‘Drugs@
FDA’’ website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
Dated: February 8, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–03012 Filed 2–12–21; 8:45 am]
BILLING CODE 4164–01–P
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
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 OXLUMO
(lumasiran) injection, manufactured by
Alnylam Pharmaceuticals Inc., meets
the criteria for a priority review
voucher.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Althea Cuff, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–4061, email: althea.cuff@
fda.hhs.gov.
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 OXLUMO
(lumasiran) injection, manufactured by
Alnylam Pharmaceuticals Inc., meets
the criteria for a priority review
voucher. OXLUMO (lumasiran)
injection is indicated for the treatment
of primary hyperoxaluria type 1 to
SUPPLEMENTARY INFORMATION:
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Food and Drug Administration
[Docket No. FDA–2017–N–5569]
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SUMMARY:
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]]>Agencies
[Federal Register Volume 86, Number 29 (Tuesday, February 16, 2021)]
[Notices]
[Page 9514]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03012]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-0026]
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 OXLUMO (lumasiran) injection, manufactured by Alnylam
Pharmaceuticals Inc., meets the criteria for a priority review voucher.
FOR FURTHER INFORMATION CONTACT: Althea Cuff, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-4061, email:
[email protected].
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 OXLUMO
(lumasiran) injection, manufactured by Alnylam Pharmaceuticals Inc.,
meets the criteria for a priority review voucher. OXLUMO (lumasiran)
injection is indicated for the treatment of primary hyperoxaluria type
1 to lower urinary oxalate levels in pediatric and adult patients.
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 OXLUMO (lumasiran) injection, go to the ``[email protected]''
website at https://www.accessdata.fda.gov/scripts/cder/daf/.
Dated: February 8, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-03012 Filed 2-12-21; 8:45 am]
BILLING CODE 4164-01-P
