Paxlovid EUA Modified to Move to NDA Product

FDA says that beginning 3/8, Pfizer’s Paxlovid that is labeled under a 12/2021 emergency use authorization will no longer be authorized for adults, and instead patients can be prescribed Paxlovid under a 5/2023 NDA approval for treating mild-to-moderate Covid-19 in adults who are at high risk for progression to severe disease, including hospitalization or death.

An FDA notice says that the 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.”

The revision to the Paxlovid EUA is the next step in transitioning from the use of EUA-labeled Paxlovid to the use of NDA-labeled Paxlovid, the agency says.