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

Streszczenie

The Food and Drug Administration (FDA or Agency) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Genentech, Inc. (Genentech) for Actemra (tocilizumab). FDA revoked this Authorization on August 8, 2025, under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocation, including an explanation of the reasons for the revocation, are reprinted in this document.