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FDA Approves Actemra (tocilizumab) Injection for Treatment of COVID-19 in Certain Hospitalized Adults

Today, FDA approved a new indication for Actemra (tocilizumab) injection for the treatment of hospitalized adult patients with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

FDA first issued an emergency use authorization (EUA) for Actemra in hospitalized adult and pediatric patients (2 years of age and older) for the same use on June 24, 2021. Actemra remains authorized for emergency use for the same indication for hospitalized pediatric patients 2 to less than 18 years of age who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.

FDA has revised the Letter of Authorization and associated fact sheets to remove the population covered under the approved indication. Common side effects of Actemra and the recommended dosage for the approved population are included in the prescribing information.

Related Information

• Revised Actemra EUA Letter of Authorization
• Revised FAQs on EUA for Actemra for Treatment of COVID-19
• EUA Fact Sheet for Health Care Providers
• EUA Fact Sheet for Patients and Caregivers
• Emergency Use Authorization: Drugs and Non-Vaccine Biological Products
• Coronavirus Treatment Acceleration Program (CTAP)
• Coronavirus Disease (COVID-19)

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