Notices. Notice
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/register/2025/12/08/2025-22211·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4164-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2025-N-5791] Revocation of Emergency Use of a Drug Product During the COVID-19 Pandemic; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: 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. DATES: The authorization is revoked as of August 8, 2025. ADDRESSES: Submit written requests for a single copy of the revocation to the Office of Executive Programs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, 6th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request or include a Fax number to which the revocation may be sent. See the SUPPLEMENTARY INFORMATION section for electronic access to the revocation. FOR FURTHER INFORMATION CONTACT: Andrea Gormley, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., 2nd Floor, Silver Spring, MD 20993-0002, 301-796-2210 (this is not a toll free number). SUPPLEMENTARY INFORMATION: I. Background Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) allows FDA to strengthen the public health protections against biological, chemical, nuclear, and radiological agents. Among other things, section 564 of the FD&C Act allows FDA to authorize the use of an unapproved medical product or an unapproved use of an approved medical product in certain situations. On June 24, 2021, FDA issued an Authorization to Genentech for Actemra (EUA 099), subject to the terms of the Authorization. Notice of the issuance of the Authorization was published in the **Federal Register** on August 5, 2021 (86 FR 42850), as required by section 564(h)(1) of the FD&C Act. The authorization of a drug for emergency use under section 564 of the FD&C Act may, pursuant to section 564(g)(2) of the FD&C Act, be revoked when the criteria under section 564(c) of the FD&C Act for issuance of such authorization are no longer met (section 564(g)(2)(B) of the FD&C Act), or other circumstances make such revocation appropriate to protect the public health or safety (section 564(g)(2)(C) of the FD&C Act). II. The Revocation On August 8, 2025, the Agency approved a supplemental Biologics License Application
(BLA)to BLA 125276, which expanded the approved indication for COVID-19 to the following: ACTEMRA® (tocilizumab) is an interleukin-6 (IL-6) receptor antagonist indicated for the treatment of: Coronavirus Disease 2019 (COVID-19), Hospitalized adult and pediatric patients aged 2 years and older with coronavirus disease 2019 (COVID-19) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Based on this approval, FDA concluded that BLA 125276 for Actemra is an adequate, approved, and available alternative to Actemra's emergency use for the treatment of COVID-19 for the purposes of section 564(c)(3) of the Act. Accordingly, FDA revoked EUA 099 for Actemra, pursuant to section 564(g)(2) of the Act. The revocation in its entirety follows and provides explanations of the reasons for revocation, as required by section 564(h)(1) of the FD&C Act. III. Electronic Access An electronic version of this document and the full text of the Authorizations are available on the internet at: *https://www.regulations.gov/.* BILLING CODE 4164-01-P EN08DE25.000 EN08DE25.001 Lowell M. Zeta, Acting Deputy Commissioner for Policy, Legislation, and International Affairs. [FR Doc. 2025-22211 Filed 12-5-25; 8:45 am]
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