Revocation of Emergency Use of a Drug During the COVID-19 Pandemic; Availability

Resumo

The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Fresenius Kabi USA, LLC (Fresenius Kabi), for Fresenius Propoven 2% Emulsion. FDA revoked the Authorization on May 10, 2022, under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocation, which includes an explanation of the reasons for the revocation, is reprinted in this document.