FDA Revokes EUA for Sotrovimab for the Treatment of COVID-19

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December 13, 2024 -- On November 22, 2024, GSK requested that the U.S. Food and Drug Administration revoke the Emergency Use Authorization for sotrovimab since all lots of sotrovimab manufactured and labeled for use under EUA 100 have expired. At the time of GSK’s request, sotrovimab was not authorized for use in geographic regions where infection is likely to have been caused by a nonsusceptible SARS-CoV-2 variant based on available information including variant susceptibility to sotrovimab 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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