The U.S. Food and Drug Administration (FDA) updated the Paxlovid Emergency Use Authorization (EUA), allowing Paxlovid that is currently in U.S. distribution to remain authorized for use through the labeled or extended expiration date, or until March 8, 2024, whichever comes first. EUA-labeled Paxlovid will no longer be authorized for emergency use after March 8.
The Paxlovid EUA will continue to authorize emergency use of Paxlovid manufactured and labeled in accordance with New Drug Application (NDA-labeled Paxlovid) for treating mild-to-moderate COVID-19 in high-risk pediatric patients (12 years of age and older) who are at high risk for progression to severe COVID-19.
Pharmacies may continue to dispense unexpired EUA-labeled Paxlovid through March 8. Any expired EUA-labeled Paxlovid and/or unused EUA-labeled Paxlovid remaining after March 8, must be returned to the manufacturer, or disposed of in accordance with federal, state and local regulations.
Patients with Paxlovid prescriptions will receive either EUA-labeled or NDA-labeled Paxlovid until March 8. After that, patients will receive NDA-labeled Paxlovid. More information about the difference in packaging between EUA-labeled and NDA-labeled Paxlovid is available on the FDA website.
Eligible patients can receive free Paxlovid through the PAXCESS Program until Dec. 31, 2024.
Members with questions may contact Kelsey Ostergren at the MHA.