2024-07657. Issuance of Priority Review Voucher; Rare Pediatric Disease Product; DUVYZAT (givinostat)

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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 (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 award of the priority review voucher. FDA has determined that DUVYZAT (givinostat), approved on March 21, 2024, manufactured by Italfarmaco S.p.A., 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.

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), FDA will award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA has determined that DUVYZAT (givinostat), manufactured by Italfarmaco S.p.A., meets the criteria for a priority review voucher. DUVYZAT (givinostat) oral suspension is indicated for the treatment of Duchenne muscular dystrophy in patients 6 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 DUVYZAT (givinostat), go to the “ Drugs@FDA ” website at https://www.accessdata.fda.gov/​scripts/​cder/​daf/​.

Dated: April 8, 2024.

Lauren K. Roth,

Associate Commissioner for Policy.