federal_register: 2025-22211

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2025-22211 Revocation of Emergency Use of a Drug Product During the COVID-19 Pandemic; Availability Notice 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. 2025-12-08 2025 12 https://www.federalregister.gov/documents/2025/12/08/2025-22211/revocation-of-emergency-use-of-a-drug-product-during-the-covid-19-pandemic-availability https://www.govinfo.gov/content/pkg/FR-2025-12-08/pdf/2025-22211.pdf Health and Human Services Department; Food and Drug Administration 221,199 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,...

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