Revocation of Emergency Use of a Drug During the COVID-19 Pandemic; Availability
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Issuing agencies
Abstract
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) issued to B. Braun Melsungen AG (B. Braun Melsungen) for Propofol-Lipuro 1% injectable emulsion (Propofol-Lipuro 1% emulsion). The EUA was issued on March 12, 2021. B. Braun Melsungen informed FDA that the inventory of the Propofol-Lipuro 1% emulsion within the United States has been depleted and that B. Braun Melsungen does not intend to offer this product in the United States anymore. Because B. Braun Melsungen has notified FDA that it does not intend to offer the Propofol-Lipuro 1% emulsion in the United States anymore and requested FDA revoke the EUA for the Propofol-Lipuro 1% emulsion, FDA has determined that it is appropriate to protect the public health or safety to revoke this authorization. The revocation, which includes an explanation of the reasons for the revocation, is reprinted in this document.
Full Text
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<title>Federal Register, Volume 88 Issue 109 (Wednesday, June 7, 2023)</title>
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[Federal Register Volume 88, Number 109 (Wednesday, June 7, 2023)]
[Notices]
[Pages 37255-37257]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-12100]
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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 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) issued to B. Braun
Melsungen AG (B. Braun Melsungen) for Propofol-Lipuro 1% injectable
emulsion (Propofol-Lipuro 1% emulsion). The EUA was issued on March 12,
2021. B. Braun Melsungen informed FDA that the inventory of the
Propofol-Lipuro 1% emulsion within the United States has been depleted
and that B. Braun Melsungen does not intend to offer this product in
the United States anymore. Because B. Braun Melsungen has notified FDA
that it does not intend to offer the Propofol-Lipuro 1% emulsion in the
United States anymore and requested FDA revoke the EUA for the
Propofol-Lipuro 1% emulsion, FDA has determined that it is appropriate
to protect the public health or safety to revoke this authorization.
The revocation, which includes an explanation of the reasons for the
revocation, is reprinted in this document.
DATES: The Authorization is revoked as of April 12, 2023.
ADDRESSES: Submit written requests for a single copy of the EUA 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. With this EUA authority, FDA can help ensure that medical
countermeasures may be used in emergencies to diagnose, treat, or
prevent serious or life-threatening diseases or conditions caused by
biological, chemical, nuclear, or radiological agents when there are no
adequate, approved, and available alternatives. On March 12, 2021, FDA
[[Page 37256]]
issued an Authorization (EUA 096) to B. Braun Melsungen for Propofol-
Lipuro 1% emulsion, subject to the terms of the Authorization. Notice
of the issuance of the Authorization was published in the Federal
Register on June 23, 2021 (86 FR 32938), as required by section
564(h)(1) of the FD&C Act.
II. The Revocation
Because B. Braun Melsungen has notified FDA that it does not intend
to offer the Propofol-Lipuro 1% emulsion in the United States anymore
and requested FDA revoke the EUA for the Propofol-Lipuro 1% emulsion,
FDA has determined that it is appropriate to protect the public health
or safety to revoke this authorization. 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.
III. Electronic Access
An electronic version of this document and the full text of the
Authorizations and revocation are available on the internet at <a href="https://www.fda.gov/drugs/emergency-preparedness-drugs/emergency-use-authorizations-drugs-and-non-vaccine-biological-products">https://www.fda.gov/drugs/emergency-preparedness-drugs/emergency-use-authorizations-drugs-and-non-vaccine-biological-products</a>.
BILLING CODE 4164-01-P
[GRAPHIC] [TIFF OMITTED] TN07JN23.026
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[GRAPHIC] [TIFF OMITTED] TN07JN23.027
Dated: June 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-12100 Filed 6-6-23; 8:45 am]
BILLING CODE 4164-01-C
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