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Remdesivir (GS-5734™) is an investigational, broad-spectrum antiviral that is currently in development for a range of infectious conditions. Remdesivir is currently being evaluated in ongoing clinical studies of patients with COVID-19. The efficacy and safety of remdesivir for the treatment of COVID-19 have not been determined, and it is not approved for any use. Remdesivir must be administered intravenously.
In response to a public health emergency, the U.S. FDA has issued an Emergency Use Authorization (EUA) for the unapproved product, remdesivir, for the treatment of COVID-19. The distribution of remdesivir has been authorized only for the treatment of hospitalized patients with severe COVID-19. This use is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use, unless the authorization is terminated or revoked sooner. For information about the authorized use of remdesivir and mandatory requirements of the Emergency Use Authorization in the U.S., please review the Fact Sheet for Healthcare Providers and FDA Letter of Authorization available below.
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