FDA revises letter of authorization for the emergency use authorization for Paxlovid
EUA-labeled Paxlovid is no longer authorized for emergency use, regardless of the labeled or extended expiration date. For both NDA-approved and EUA-authorized uses, only NDA-labeled Paxlovid may be dispensed. Today’s revision to the Paxlovid EUA completes FDA’s transition to FDA-approved Paxlovid from EUA-labeled Paxlovid. All EUA-labeled Paxlovid, including expired EUA-labeled Paxlovid, remaining in U.S. distribution […]
