90 FR 143 pgs. 35685-35689 - Revocation of Emergency Use of a Drug Product During the COVID-19 Pandemic; Availability
Type: NOTICEVolume: 90Number: 143Pages: 35685 - 35689
Pages: 35685, 35686, 35687, 35688, 35689Docket number: [Docket No. FDA-2025-N-1892]
FR document: [FR Doc. 2025-14233 Filed 7-28-25; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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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.
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
[top] Having concluded that the criteria for revocation of the Authorizations under section 564(g)(2)(C) of the FD&C Act are
IV. 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/ .
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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]
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