Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted)
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Issuing agencies
Abstract
The Food and Drug Administration (FDA) is announcing the approval of a product redeeming a rare pediatric disease 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 rare pediatric disease priority review vouchers as well as the approval of products redeeming vouchers. FDA has determined that AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted), BLA supplement approved June 7, 2024, meets the criteria for redeeming a priority review voucher.
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<title>Federal Register, Volume 91 Issue 73 (Thursday, April 16, 2026)</title>
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[Federal Register Volume 91, Number 73 (Thursday, April 16, 2026)]
[Notices]
[Page 20460]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-07368]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-3446]
Notice of Approval of Product Under Voucher: Rare Pediatric
Disease Priority Review Voucher; AREXVY (Respiratory Syncytial Virus
Vaccine, Adjuvanted)
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
approval of a product redeeming a rare pediatric disease 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 rare
pediatric disease priority review vouchers as well as the approval of
products redeeming vouchers. FDA has determined that AREXVY
(Respiratory Syncytial Virus Vaccine, Adjuvanted), BLA supplement
approved June 7, 2024, meets the criteria for redeeming a priority
review voucher.
FOR FURTHER INFORMATION CONTACT: Myrna Hanna, Center for Biologics
Evaluation and Research, Food and Drug Administration,
<a href="/cdn-cgi/l/email-protection#c5acaba1b0b6b1b7bceba7acaaa9aaa2aca6b685a3a1a4ebadadb6eba2aab3"><span class="__cf_email__" data-cfemail="5930373d2c2a2d2b20773b303635363e303a2a193f3d387731312a773e362f">[email protected]</span></a>, 240-402-7911.
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 AREXVY (Respiratory Syncytial Virus Vaccine,
Adjuvanted) 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 AREXVY (Respiratory Syncytial Virus Vaccine,
Adjuvanted), go to the Center for Biologics Evaluation and Research
Approved Products website at <a href="https://www.fda.gov/vaccines-blood-biologics/center-biologics-evaluation-and-research-cber-product-approval-information">https://www.fda.gov/vaccines-blood-biologics/center-biologics-evaluation-and-research-cber-product-approval-information</a>.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-07368 Filed 4-15-26; 8:45 am]
BILLING CODE 4164-01-P
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