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# Paxlovid EUA Modified to Move to NDA Product
- URL: https://www.fdaweb.com/paxlovid-eua-modified-to-move-to-nda-product/
- Published: 2024-01-29T12:00:00.000Z
- Updated: 2026-09-14T14:21:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156237

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](https://www.fda.gov/drugs/drug-safety-and-availability/fda-revises-letter-authorization-emergency-use-authorization-paxlovid?ref=fdaweb.com) 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.