FDA Cancels Authorization to Treat COVID With Sotrovimab
By Joey Berlin

The monoclonal antibody sotrovimab is no longer authorized to treat COVID-19 in the U.S. following the Food and Drug Administration’s (FDA’s) decision to pull its emergency use authorization.

FDA announced the update on April 5, noting sotrovimab is “unlikely to be effective” against the Omicron BA.2 subvariant of COVID, now the dominant strain in the U.S.

“Health care providers should use other approved or authorized products as they choose appropriate treatment options for patients,” FDA said in announcing the update.

The Texas Department of State Health Services, in an email to COVID therapeutic administrators, said sotrovimab administered after April 5 must be reported as a medication error to MedWatch, FDA’s medical product safety reporting program. Those reports can be made online, by phone at (800) FDA 1088, or by fax at (800) FDA-0178.

Last Updated On

April 06, 2022

Originally Published On

April 06, 2022

Related Content