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VEKLURY® (REMDESIVIR) RESOURCES
Veklury® (remdesivir) is an antiviral product that is being studied in multiple ongoing international clinical trials. In recognition of the current public health emergency and based on available clinical data, the approval status of remdesivir varies by country. In countries where remdesivir has not been approved by the regional health authority, remdesivir is an investigational drug, and the safety and efficacy of remdesivir have not been established. In the United States (U.S.), remdesivir has not been approved by the U.S. Food and Drug Administration (FDA) for any use.
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.
This information is updated regularly, please check back for updates.