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U.S. Department of Health and Human Services

Bamlanivimab

Important Updates

September 3, 2021 -  HHS implements update to mAb distribution process to help promote optimal and equitable use of the available supply of mAbs while efforts to procure additional product. Learn More >>

September 2, 2021 -  FDA and ASPR announce resumption in use and distribution of bamlanivimab/etesevimab in all U.S states, territories, and jurisdictions under the conditions of authorization for EUA 94Learn More >>

August 27, 2021 -  FDA and ASPR announce resumption in use and distribution of bamlanivimab/etesevimab in certain states. Learn More >>

August 20, 2021 - FDA and ASPR announce the shelf-life extension of bamlanivimab under Emergency Use Authorization for bamlanivimab and etesevimab administered together, extending the shelf life from 12 months to 18 months. Learn More »

April 16, 2021 - FDA revoked the Emergency Use Authorization for bamlanivimab, when administered alone, for the treatment of mild to moderate COVID-19 in high risk adults and certain pediatric patients.  Learn More »

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On September 2, 2021, FDA and ASPR announced the authorization of the use the use of bamlanivimab and etesevimab, administered together, in all U.S. states, territories, and U.S. jurisdictions in which recent data shows the combined frequency of variants resistant to bamlanivimab and etesevimab administered together is less than or equal to 5%. Bamlanivimab and etesevimab, administered together, will not be authorized for use in states, territories, and U.S. jurisdictions in which recent data shows the combined frequency of variants resistant to bamlanivimab and etesevimab administered together exceeds 5%.

FDA has posted a list of states, territories, and U.S. jurisdictions in which bamlanivimab and etesevimab administered together are currently authorized, and a list of states, territories, and U.S. jurisdictions in which bamlanivimab and etesevimab, administered together, are not currently authorized and will periodically update both lists as new data and information becomes available. FDA will make this determination considering current variant frequency data, trends in variant frequency over time, and the precision of the estimates and information regarding emerging variants of concern.

In addition to bamlanivimab/etesevimab, REGEN-COV and sotrovimab received FDA emergency use authorization for the treatment of eligible individuals.  

Shelf Life Extension Federal Distribution Emergency Use Authorization (Revoked)

 

  • This page last reviewed: October 13, 2021