Are COVID-19 treatments FDA approved?

Oral antiviral therapies to treat mild to moderate COVID-19 include PAXLOVID™and LAGREVIO™ (molnupiravir). These antiviral treatments have been authorized for use in patients with COVID-19 under an Emergency Use Authorization (EUA). 

An Emergency Use Authorization (EUA) is an authority granted to the U.S. Food and Drug Administration (FDA) to make unapproved medical products such as vaccines or other drugs available during public health emergencies. An EUA does not mean that a drug is unsafe, untested, or ineffective. Emergency use authorization is NOT the same as FDA approval or licensure.