Molnupiravir is authorized for emergency use by FDA under an EUA to treat mild-to-moderate COVID-19 in adults or with recent exposure to COVID-19, and the treatment of adults with recent exposure to COVID-19, who are at high risk for progression to severe COVID-19 including hospitalization or death, and for whom other COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate.
Molnupiravir isn’t authorized for use in people less than 18 years of age, for prevention of COVID-19, for people needing hospitalization for COVID-19, or for use for longer than 5 consecutive days. Molnupiravir isn’t recommended for use in pregnancy as it may cause harm to an unborn baby. Molnupiravir may cause side effects, some of which may be serious and unexpected. Learn more about Molnupiravir on the manufacturer’s website and review the patient and healthcare provider fact sheets for more information.
The emergency use of Molnupiravir is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb3(b)(1), unless the declaration is terminated or authorization revoked sooner.
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