FDA Revokes Emergency Use Authorization (EUA) for Bebtelovimab for the Treatment of COVID-19

Follow Drugslib on

December 13, 2024 -- On December 5, 2024, Lilly requested that the U.S. Food and Drug Administration revoke the Emergency Use Authorization for bebtelovimab since all lots of bebtelovimab manufactured and labeled for use under EUA 111 have expired. At the time of Lilly’s request, bebtelovimab was not authorized for use in geographic regions of the United States where infection is likely to have been caused by a non-susceptible SARS-CoV-2 variant based on available information including variant susceptibility to bebtelovimab and regional variant frequency. FDA has determined that it is appropriate to protect the public health or safety to revoke this authorization.

Posted : 2024-12-17 06:00

Read more

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Popular Keywords