Rules and Regulations. Notice
/register/2025/01/15/2025-00750·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Agency: Food and Drug Administration, HHS
Action: Notice
Citation: FR Doc. 2025-00750 · Docket No. FDA-2020-N-0026
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 ALHEMO (concizumab-mtci), approved on December 20, 2024, manufactured by Novo Nordisk, Inc., meets the criteria for a priority review voucher.
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 ALHEMO (concizumab-mtci), manufactured by Novo Nordisk, Inc., meets the criteria for a priority review voucher. ALHEMO (concizumab-mtci) injection is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A (congenital factor VIII deficiency) with FVIII inhibitors and hemophilia B (congenital factor IX deficiency) with FIX inhibitors. 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 . For further information about ALHEMO (concizumab-mtci), go to the “ Drugs@FDA ” website at . Dated: January 8, 2025. P. Ritu Nalubola, Associate Commissioner for Policy. [FR Doc. 2025-00750 Filed 1-14-25; 8:45 am]