Issuance of Priority Review Voucher; Rare Pediatric Disease Product
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Issuing agencies
Abstract
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 (the 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 JOENJA (leniolisib), approved March 24, 2023, and manufactured by Pharming Technologies B.V., meets the criteria for a priority review voucher.
Full Text
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<title>Federal Register, Volume 88 Issue 78 (Monday, April 24, 2023)</title>
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[Federal Register Volume 88, Number 78 (Monday, April 24, 2023)]
[Notices]
[Pages 24806-24807]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-08518]
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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.
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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 (the FD&C Act), as amended by the Food and Drug
[[Page 24807]]
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 JOENJA (leniolisib), approved March 24, 2023,
and manufactured by Pharming Technologies B.V., meets the criteria for
a priority review voucher.
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#c98aa8bda1bbb0a7e785acac89afada8e7a1a1bae7aea6bf"><span class="__cf_email__" data-cfemail="286b495c405a514606644d4d684e4c490640405b064f475e">[email protected]</span></a>.
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 JOENJA
(leniolisib), manufactured by Pharming Technologies B.V., meets the
criteria for a priority review voucher.
JOENJA (leniolisib) is a kinase inhibitor indicated for the
treatment of activated phosphoinositide 3-kinase delta (PI3K[delta])
syndrome (APDS) in adult and pediatric patients 12 years of age or
older.
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 JOENJA (leniolisib), 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 18, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-08518 Filed 4-21-23; 8:45 am]
BILLING CODE 4164-01-P
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