FDA’s EUA page lists all therapeutic products currently authorized under an EUA, as well as the current product Fact Sheets and additional information for health care providers and patients.

FDA and HHS/ASPR have announced extensions to the shelf life for some EUA products. These updates can be found on FDA’s Expiration Dating Extension page.

SARS-COV-2-targeting Monoclonal Antibodies 

SARS-COV-2-targeting monoclonal antibodies (mAbs) are laboratory-produced antibodies that can help the immune system's attack on SARS-COV-2. These mAbs block entry into human cells, thus neutralizing the virus. The following SARS-COV-2-targeting mAbs are authorized for use through an EUA. 

Like other infectious organisms, SARS-CoV-2 can mutate over time, resulting in genetic variation in the population of circulating viral strains. Some variants can cause resistance to one or more of the mAb therapies authorized to treat COVID-19. Due to the high frequency of variants circulating within the United States that are not susceptible to the following mAbs, the treatments below are not currently authorized in any U.S. region until further notice by FDA and may not be administered for the treatment of COVID-19 under the EUA:

Antiviral Drugs 

Antiviral drugs are prescription medicines (pills, liquid, an inhaled powder, or an intravenous solution) that fight against viruses in your body. 

As noted above, Veklury (remdesivir) is approved for the treatment of COVID-19 in adults and pediatric patients (28 days of age and older and weighing at least 3 kilograms) with positive results of direct SARS-CoV-2 viral testing, who are: hospitalized, or not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death. 

Immune Modulators 

Immune modulators are a category of drugs that help activate, boost, or suppress the immune function. In the case of COVID-19 infection, the immune system can become hyperactive which may result in worsening of disease. Immune modulators can help suppress this hyperinflammation.   

• Kineret (anakinra) is authorized for the treatment of COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR).
• Olumiant (baricitinib) is authorized for the treatment of COVID-19 in pediatric patients 2 to less than 18 years of age requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygen (ECMO). 
• Actemra (tocilizumab)  

As noted above, Olumiant (baricitinib) is approved for the same indication for hospitalized adult patients.

Sedatives 

Sedatives are drugs that maintain sedation, generally via continuous intravenous infusion, in patients who are intubated and require mechanical ventilation in an intensive care unit (ICU) setting. The following sedatives are authorized for emergency use:  

Renal Replacement Therapies  

Continuous renal replacement therapy (CRRT) is a type of “dialysis,” which is a machine treatment that filters and purifies the blood when a patient’s kidneys are damaged or are not functioning normally. CRRT is used for patients with kidney injury in acute care settings.  

SARS-CoV-2 led to an increased population with critical illness and multiple organ failure, including acute kidney injury, increasing the need for CRRT. In addition, there was an insufficient supply of replacement solutions to meet the emergency need to provide CRRT in critically ill patients. 

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