Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher
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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), 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 priority review vouchers as well as the approval of products redeeming a priority review voucher. FDA has determined that the supplemental application for ULTOMIRIS (ravulizumab-cwvz), approved April 27, 2022, meets the redemption criteria.
Full Text
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<title>Federal Register, Volume 87 Issue 122 (Monday, June 27, 2022)</title>
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[Federal Register Volume 87, Number 122 (Monday, June 27, 2022)]
[Notices]
[Page 38167]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-13628]
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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
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), 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 priority
review vouchers as well as the approval of products redeeming a
priority review voucher. FDA has determined that the supplemental
application for ULTOMIRIS (ravulizumab-cwvz), approved April 27, 2022,
meets the redemption criteria.
FOR FURTHER INFORMATION CONTACT: Cathryn Lee, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-1394, email:
<a href="/cdn-cgi/l/email-protection#d291b3a6baa0abbcfc9eb7b792b4b6b3fcbabaa1fcb5bda4"><span class="__cf_email__" data-cfemail="e3a082978b919a8dcdaf8686a3858782cd8b8b90cd848c95">[email protected]</span></a>.
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 the
supplemental application for ULTOMIRIS (ravulizumab-cwvz), approved
April 27, 2022, 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="http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasesPriorityVoucherProgram/default.htm">http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasesPriorityVoucherProgram/default.htm</a>. For further
information about ULTOMIRIS (ravulizumab-cwvz), approved April 27,
2022, go to the ``Drugs@FDA'' website at <a href="http://www.accessdata.fda.gov/scripts/cder/daf/">http://www.accessdata.fda.gov/scripts/cder/daf/</a>.
Dated: June 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-13628 Filed 6-24-22; 8:45 am]
BILLING CODE 4164-01-P
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