Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19 | FDA
The FDA first issued an emergency use authorization (EUA) for Olumiant in combination with remdesivir to treat COVID-19 in hospitalized adults and pediatric patients on November 19, 2020. On July 28, 2021, the FDA revised the EUA to authorize Olumiant as a standalone treatment. Olumiant remains under EUA status for hospitalized pediatric patients 2 to less than 18 years of age requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. The FDA has revised the Letter of Authorization and associated fact sheets to remove the population covered under the approved indication.
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