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Sotrovimab Monoclonal Antibody Treatment No Longer Authorized for Use in U.S.

April 06, 2022

 


Contact:
 Communications Office
 NewsMedia@flhealth.gov
 850-245-4111

Tallahassee, Fla. —

 

Sotrovimab Monoclonal Antibody Treatment

No Longer Authorized for Use in U.S.

 

On April 5, 2022, the U.S. Food and Drug Administration (FDA) reissued the emergency use authorization (EUA) for GSK-Vir Biotechnology’s sotrovimab monoclonal antibody treatment.

Sotrovimab is no longer authorized for use in any U.S. state, territory, or jurisdiction at this time. The full FDA press release can be found here.

This decision leaves the State of Florida with only a single monoclonal antibody treatment, bebtelovimab.

Corresponding revisions have been made to the authorized fact sheets for sotrovimab. These fact sheets are available on the FDA’s website.

As a result of the reissued EUAs, health care practitioners in Florida are no longer authorized to administer these monoclonal antibody treatments to patients, effective immediately.

Resources for emerging treatments can be found at HealthierYouFL.org. Providers that have received allocations of antiviral treatments, bebtelovimab monoclonal antibodies, and evusheld pre-exposure prophylaxis can be found at FloridaHealthCOVID19.gov.

 

Corrections & Clarifications


Original Published 7:43 PM ET, Wed April 06, 2022 | C&C on 9:57 AM ET, Mon April 11, 2022
Original: This decision leaves the State of Florida with only a single post-exposure monoclonal antibody treatment, bebtelovimab.
C&C: This decision leaves the State of Florida with only a single monoclonal antibody treatment, bebtelovimab.
RFC: Re-word this content to be consistent with the EUA.