Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher, 59386 [2018-25480]
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Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Notices
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[FR Doc. 2018–25548 Filed 11–21–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
amozie on DSK3GDR082PROD with NOTICES1
[Docket No. FDA–2018–N–1262]
Approval of Product Under Voucher:
Rare Pediatric Disease Priority Review
Voucher
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Sep<11>2014
18:33 Nov 21, 2018
Jkt 247001
Annual
number of
respondents
16
12
48
60
104
160
48
8
6
24
30
52
80
24
The Food and Drug
Administration (FDA) is announcing the
issuance of approval of a product
redeeming a priority review voucher.
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
issuance of vouchers as well as the
approval of products redeeming a
voucher. FDA has determined that
AJOVY (fremanezumab-vfrm), approved
September 14, 2018, meets the
redemption criteria.
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, Fax: 301–796–9858,
email: althea.cuff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under
section 529 of the FD&C Act (21 U.S.C.
360ff), which was added by FDASIA,
FDA will report the issuance of rare
pediatric disease priority review
vouchers and the approval of products
for which a voucher was redeemed.
FDA has determined that AJOVY
(fremanezumab-vfrm), approved
September 14, 2018, meets the
redemption criteria.
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 AJOVY
(fremanezumab-vfrm) go to the ‘‘Drugs@
FDA’’ website at https://
SUMMARY:
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
Average
burden hours
per response
1
1
4
2
1
1
2
Annual burden
hours
8
8
1
1
1
2
12
64
48
96
60
52
160
576
www.accessdata.fda.gov/scripts/cder/
daf/.
Dated: November 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–25480 Filed 11–21–18; 8:45 am]
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HUMAN SERVICES
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E:\FR\FM\23NON1.SGM
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[Federal Register Volume 83, Number 226 (Friday, November 23, 2018)]
[Notices]
[Page 59386]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-25480]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-1262]
Approval of Product Under Voucher: Rare Pediatric Disease
Priority Review Voucher
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of approval of a product redeeming a priority review voucher.
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 issuance of vouchers
as well as the approval of products redeeming a voucher. FDA has
determined that AJOVY (fremanezumab-vfrm), approved September 14, 2018,
meets the redemption criteria.
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, Fax: 301-
796-9858, email: [email protected].
SUPPLEMENTARY INFORMATION: Under section 529 of the FD&C Act (21 U.S.C.
360ff), which was added by FDASIA, FDA will report the issuance of rare
pediatric disease priority review vouchers and the approval of products
for which a voucher was redeemed. FDA has determined that AJOVY
(fremanezumab-vfrm), approved September 14, 2018, meets the redemption
criteria.
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 AJOVY (fremanezumab-vfrm) go to the ``[email protected]''
website at https://www.accessdata.fda.gov/scripts/cder/daf/.
Dated: November 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-25480 Filed 11-21-18; 8:45 am]
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