[Federal Register Volume 89, Number 48 (Monday, March 11, 2024)]
[Notices]
[Pages 17475-17477]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-05085]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-2057]


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 Authorization (EUA) (the Authorization) 
issued to Eli Lilly and Co. (Lilly), for bamlanivimab and etesevimab 
administered together. FDA revoked the Authorization on December 14, 
2023, under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The 
revocation, which includes an explanation of the reasons for the 
revocation, is reprinted in this document.

DATES: The Authorization is revoked as of December 14, 2023.

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 Authorization may be sent. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the 
Authorization.

FOR FURTHER INFORMATION CONTACT: Johanna McLatchy, 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, 301-796-3200 (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 February 9, 2021, FDA issued an Authorization (EUA 094) 
to Lilly for bamlanivimab and etesevimab administered together, subject 
to the terms of the Authorization. Notice of the issuance of the 
Authorization was published in the Federal Register on May 27, 2021 (86 
FR 28608), 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 Request

    In a request received by FDA on October 23, 2023, Lilly requested 
revocation of, and on December 14, 2023, FDA revoked, the Authorization 
for bamlanivimab and etesevimab

[[Page 17476]]

administered together. Because Lilly has informed FDA that all lots of 
bamlanivimab and etesevimab manufactured and labeled for use under EUA 
094 have expired, and that Lilly does not intend to offer this product 
in the United States anymore, Lilly requested FDA revoke the EUA for 
bamlanivimab and etesevimab administered together. FDA has determined 
that it is appropriate to protect the public health or safety to revoke 
this Authorization.

III. The Revocation

    Having concluded that the criteria for revocation of the 
Authorization under section 564(g)(2)(C) of the FD&C Act are met, FDA 
has revoked the EUA for bamlanivimab and etesevimab administered 
together. The revocation in its entirety follows and provides an 
explanation 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 
Authorization is available on the internet at: https://www.regulations.gov.
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    Dated: March 5, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-05085 Filed 3-8-24; 8:45 am]
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