FDA Issues Revisions of Emergency Use Authorization for Paxlovid

The FDA recently announced a revision to the Paxlovid emergency use authorization (EUA). EUA-labeled Paxlovid will no longer be authorized for emergency use after March 8, 2024, regardless of the labeled or extended expiration date.

Paxlovid EUA will continue to authorize emergency use of Paxlovid manufactured and labeled in accordance with the NDA (NDA-labeled Paxlovid) for the treatment of mild-to-moderate COVID-19 in pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death.

Expired EUA-labeled Paxlovid must be returned to the manufacturer or disposed of in accordance with all federal, state, and local regulations. Similarly, after March 8, 2024, all EUA-labeled Paxlovid remaining in U.S. distribution must also be returned to the manufacturer or disposed of in accordance with all federal, state, and local regulations.

Read the full FDA revision notice here.