💊FDA Issues Priority Review Voucher for EBANGA Medical Countermeasure
Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product; EBANGA
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.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The issuance of a priority review voucher for EBANGA indicates potential financial benefits for Ridgeback Biotherapeutics, as the voucher can incentivize further investment and expedite product approval approval processes. This can stimulate more business in the medical countermeasure sector and influence strategic planning for companies involved in pharmaceutical development.