88 FR 78 pgs. 24806-24807 - Issuance of Priority Review Voucher; Rare Pediatric Disease Product
Type: NOTICEVolume: 88Number: 78Pages: 24806 - 24807
Pages: 24806, 24807Docket number: [Docket No. FDA-2020-N-0026]
FR document: [FR Doc. 2023-08518 Filed 4-21-23; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
[top]
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.
SUMMARY:
[top] 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
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: Cathryn.Lee@fda.hhs.gov.
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 (PI3Kd) 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 https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm. For further information about JOENJA (leniolisib), go to the "Drugs@FDA" website at https://www.accessdata.fda.gov/scripts/cder/daf/.
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