Notice2025-14233
Revocation of Emergency Use of a Drug Product During the COVID-19 Pandemic; Availability
Primary source
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Published
July 29, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Regeneron Pharmaceuticals, Inc. (Regeneron) for REGEN-COV (casirivimab and imdevimab administered together), to GlaxoSmithKline LLC (GSK) for sotrovimab, to Eli Lilly and Company (Lilly) for bebtelovimab, and to AstraZeneca Pharmaceuticals LP (AstraZeneca) for EVUSHELD (tixagevimab co-packaged with cilgavimab). FDA revoked these Authorizations on December 13, 2024, under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocations, including an explanation of the reasons for the revocations, are reprinted in this document.
Full Text
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<title>Federal Register, Volume 90 Issue 143 (Tuesday, July 29, 2025)</title>
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[Federal Register Volume 90, Number 143 (Tuesday, July 29, 2025)]
[Notices]
[Pages 35685-35689]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-14233]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-1892]
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) is announcing the
revocation of the Emergency Use Authorizations (EUAs) (the
Authorizations) issued to Regeneron Pharmaceuticals, Inc. (Regeneron)
for REGEN-COV (casirivimab and imdevimab administered together), to
GlaxoSmithKline LLC (GSK) for sotrovimab, to Eli Lilly and Company
(Lilly) for bebtelovimab, and to AstraZeneca Pharmaceuticals LP
(AstraZeneca) for EVUSHELD (tixagevimab co-packaged with cilgavimab).
FDA revoked these Authorizations on December 13, 2024, under the
Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocations,
including an explanation of the reasons for the revocations, are
reprinted in this document.
DATES: The Authorizations are revoked as of December 13, 2024.
ADDRESSES: Submit written requests for a single copy of the revocations
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 revocations may be sent. See the
SUPPLEMENTARY INFORMATION section for electronic access to the
revocations.
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 November 21, 2020, FDA issued an Authorization to Regeneron for
REGEN-COV (EUA 091), subject to the terms of the Authorization. Notice
of the issuance of the Authorization was published in the Federal
Register on February 19, 2021 (86 FR 10290), as required by section
564(h)(1) of the FD&C Act.
On May 26, 2021, FDA issued an Authorization to GSK for sotrovimab
(EUA 100), 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.
On December 8, 2021, FDA issued an Authorization to AstraZeneca for
EVUSHELD (EUA 104), subject to the terms of the Authorization. Notice
of the issuance of the Authorization was published in the Federal
Register on February 4, 2022 (87 FR 6578), as required by section
564(h)(1) of the FD&C Act.
On February 11, 2022, FDA issued an Authorization to Lilly for
bebtelovimab (EUA 111), subject to the terms of the Authorization.
Notice of the issuance of the Authorization was published in the
Federal Register on March 22, 2022 (87 FR 16201), 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. EUA Revocation Requests
In a request received by FDA on November 25, 2024, Regeneron
requested revocation of, and on December 13, 2024, FDA revoked, the
Authorization for REGEN-COV. Because Regeneron has informed FDA that
all lots of REGEN-COV manufactured, labeled, and distributed for use
under EUA 091 have expired, and that Regeneron does not intend to offer
this product in the United States anymore, Regeneron requested FDA
revoke the EUA for REGEN-COV. FDA has determined that it is appropriate
to protect the public health or safety to revoke this Authorization.
In a request received by FDA on November 22, 2024, GSK requested
revocation of, and on December 13, 2024, FDA revoked, the Authorization
for sotrovimab. Because GSK has informed FDA that all lots of
sotrovimab manufactured, labeled, and distributed for use under EUA 100
have expired, and that GSK does not intend to offer this product in the
United States anymore, GSK requested FDA revoke the EUA for sotrovimab.
FDA has determined that it is appropriate to protect the public health
or safety to revoke this Authorization.
In a request received by FDA on November 21, 2024, AstraZeneca
requested revocation of, and on December 13, 2024, FDA revoked, the
Authorization for EVUSHELD. Because AstraZeneca has informed FDA that
all lots of EVUSHELD manufactured, labeled, and distributed for use
under EUA 104 have expired, and that AstraZeneca does not intend to
offer this product in the United States anymore, AstraZeneca requested
FDA revoke the EUA for EVUSHELD. FDA has determined that it is
appropriate to protect the public health or safety to revoke this
Authorization.
In a request received by FDA on December 5, 2024, Lilly requested
revocation of, and on December 13, 2024, FDA revoked, the Authorization
for bebtelovimab. Because Lilly has informed FDA that all lots of
bebtelovimab manufactured, labeled, and distributed for use under EUA
111 have expired, and that Lilly does not intend to offer this product
in the United States anymore, Lilly requested FDA revoke the EUA for
bebtelovimab. FDA has determined that it is appropriate to protect the
public health or safety to revoke this Authorization.
III. The Revocations
Having concluded that the criteria for revocation of the
Authorizations under section 564(g)(2)(C) of the FD&C Act are
[[Page 35686]]
met, FDA has revoked the EUAs for REGEN-COV, sotrovimab, bebtelovimab,
and EVUSHELD. These revocations in their entirety follow and provide
explanations of the reasons for revocation, as required by section
564(h)(1) of the FD&C Act.
IV. 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> gov/.
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Dated: July 23, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-14233 Filed 7-28-25; 8:45 am]
BILLING CODE 4164-01-C
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