Notice2025-22211
Revocation of Emergency Use of a Drug Product During the COVID-19 Pandemic; Availability
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 8, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 90 Issue 233 (Monday, December 8, 2025)</title>
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[Federal Register Volume 90, Number 233 (Monday, December 8, 2025)]
[Notices]
[Pages 56770-56772]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-22211]
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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.
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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[supreg] (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: <a href="https://www.regulations.gov/">https://www.regulations.gov/</a>.
BILLING CODE 4164-01-P
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Lowell M. Zeta,
Acting Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2025-22211 Filed 12-5-25; 8:45 am]
BILLING CODE 4164-01-C
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</html>Indexed from Federal Register on December 8, 2025.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.