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