FDA Revises Emergency Use of Paxlovid

The revision is a step toward finalizing the transition from Paxlovid’s emergency use authorization to its new drug application label, initiated in late 2023.

Pfizer's Paxlovid in a file photograph. Wolfgang Rattay/Reuters/Illustration

The U.S. Food and Drug Administration (FDA) stated in a revised emergency use authorization that Paxlovid sold in the United States is authorized for use only through March 8, 2024, or the extended expiration date stamped on the medication’s label.

Paxlovid is an antiviral medication prescribed to patients to treat mild-to-moderate symptoms of COVID-19. It is approved for use in individuals 12 and older who weigh at least 88 pounds and who are considered at high risk of the disease worsening, such as hospitalization or death. These people may include those with cancer, chronic diseases, weakened immune systems, and obesity. The drug has been used since 2021 under emergency use authorization (EUA).