FDA Finally Catches Up on COVID Drug Revocation
Published Date: 12/8/2025
Notice
Summary
The FDA has officially ended the emergency use of the drug Actemra (tocilizumab) for COVID-19 as of August 8, 2025. This change affects hospitals and patients who were using Actemra under emergency rules, meaning it’s no longer authorized for COVID-19 treatment. No new costs or payments are involved, but healthcare providers need to switch to other approved treatments.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Actemra Approved for Hospitalized Patients
On August 8, 2025, FDA approved a supplemental Biologics License Application expanding Actemra's approved indication to treat COVID-19 in hospitalized adult and pediatric patients aged 2 years and older who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Because this approved indication is an adequate alternative, FDA revoked the EUA for Actemra.
EUA for Actemra Revoked
The FDA revoked the Emergency Use Authorization (EUA) for Actemra (tocilizumab) for COVID-19 as of August 8, 2025. This means hospitals and patients using Actemra under the EUA can no longer use it under that emergency authorization and healthcare providers need to switch to other approved treatments; the notice states no new costs or payments are involved.
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