Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; AMVUTTRA (vutrisiran)
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Issuing agencies
Abstract
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) 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 priority review vouchers as well as the approval of products redeeming a priority review voucher. FDA has determined that the supplemental application (Supplement-06) for AMVUTTRA (vutrisiran), approved March 20, 2025, meets the criteria for redeeming a priority review voucher.
Full Text
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<title>Federal Register, Volume 90 Issue 75 (Monday, April 21, 2025)</title>
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[Federal Register Volume 90, Number 75 (Monday, April 21, 2025)]
[Notices]
[Page 16693]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-06785]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-1262]
Notice of Approval of Product Under Voucher: Rare Pediatric
Disease Priority Review Voucher; AMVUTTRA (vutrisiran)
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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) 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 priority review vouchers
as well as the approval of products redeeming a priority review
voucher. FDA has determined that the supplemental application
(Supplement-06) for AMVUTTRA (vutrisiran), approved March 20, 2025,
meets the criteria for redeeming a priority review voucher.
FOR FURTHER INFORMATION CONTACT: Quyen Tran, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20993-0002, 301-796-2771, email:
<a href="/cdn-cgi/l/email-protection#93c2e6eaf6fdbdc7e1f2fda2d3f5f7f2bdfbfbe0bdf4fce5"><span class="__cf_email__" data-cfemail="30614549555e1e6442515e01705654511e5858431e575f46">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: FDA is announcing the approval of a product
redeeming a rare pediatric disease priority review voucher. Under
section 529 of the FD&C Act (21 U.S.C. 360ff), 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 the supplemental application (Supplement-06) for
AMVUTTRA (vutrisiran) 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 <a href="https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm">https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm</a>. For further
information about AMVUTTRA (vutrisiran), go to the ``Drugs@FDA''
website at <a href="https://www.accessdata.fda.gov/scripts/cder/daf/">https://www.accessdata.fda.gov/scripts/cder/daf/</a>.
Dated: April 14, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-06785 Filed 4-18-25; 8:45 am]
BILLING CODE 4164-01-P
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