FDA – EUA-labeled Paxlovid no longer authorized for emergency use.

Emergency Use Authorization (EUA)-labeled Paxlovid (nirmatrelvir and ritonavir) is no longer authorized for emergency use, regardless of the labeled or extended expiration date: https://t.co/rUt1JvapR8 pic.twitter.com/jdSQiLT2aW

— FDA Drug Information (@FDA_Drug_Info) March 13, 2024

03/13/2024] 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 must be returned to the manufacturer or disposed of in accordance with all federal, state, and local regulations.

https://www.fda.gov/drugs/drug-safety-and-availability/fda-revises-letter-authorization-emergency-use-authorization-paxlovid