FDA Revises Pfizer’s Paxlovid Emergency Use Authorization Usage

FDA has revised Pfizer’s Paxlovid authorization, stating that the drug manufactured and labeled in accordance with the EUA will no longer be authorized for emergency use after March 8, regardless of the labeled or extended expiration date.

• Revision is next phase in the transition from use of EUA-labeled Paxlovid to the use of NDA-labeled Paxlovid
  • Transition began Nov. 1
• Paxlovid EUA will continue to authorize emergency use for treatment of mild-to-moderate infection in pediatric patients (12 yrs of age and older weighing at least 40 kg) who are at high risk for progression to severe Covid-19, incl hospitalization or death ...