FDA Revokes EUA for Evusheld (tixagevimab co-packaged with cilgavimab) for the Treatment of COVID-19
December 13, 2024 -- On November 21, 2024, AstraZeneca requested that the U.S. Food and Drug Administration revoke the Emergency Use Authorization for Evusheld (tixagevimab co-packaged with cilgavimab) since all lots of Evusheld distributed under EUA 104 have expired. At the time of AstraZeneca’s request, Evusheld was not authorized for use in any region of the United States due to the national combined frequency of non-susceptible variants circulating in the United States being more than 90%, based on available information including variant susceptibility to Evusheld and national variant frequencies. FDA has determined that it is appropriate to protect the public health or safety to revoke this authorization.
Posted: December 2024
Evusheld (tixagevimab co-packaged with cilgavimab) FDA Approval History
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