Rules and Regulations. Notice
/register/2025/04/23/2025-06970·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. 2025-06970 · Docket No. FDA-2025-N-0647
Summary
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a material threat medical countermeasure (MCM) product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved material threat MCM product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that EBANGA (ansuvimab-zykl) for injection, approved on December 21, 2020, manufactured by Ridgeback Biotherapeutics, LP, meets the criteria for a material threat MCM priority review voucher.
Supplementary Information
FDA is announcing the issuance of a material threat MCM priority review voucher to the sponsor of an approved material threat MCM product application. Under section 565A of the FD&C Act (21 U.S.C. 360bbb-4a), FDA will award priority review vouchers to sponsors of approved material threat MCM product applications that meet certain criteria upon approval of those applications. FDA has determined EBANGA (ansuvimab-zykl), manufactured by Ridgeback Biotherapeutics, LP, meets the criteria for a material threat MCM priority review voucher. EBANGA was approved on December 21, 2020, for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection. For further information about the material threat MCM Priority Review Voucher Program and for a link to the full text of section 565A of the FD&C Act, go to . For further information about EBANGA (ansuvimab-zykl) for injection, go to the “Drugs@FDA” website at . Dated: April 16, 2025. Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs. [FR Doc. 2025-06970 Filed 4-22-25; 8:45 am]