Paxlovid that was previously authorized for emergency use in the United States is no longer approved under that authorization and must be returned to the manufacturer, according to the U.S. Food and Drug Administration (FDA).

However, this change does not affect the availability of the drug for patients suffering from COVID-19 symptoms. Instead, the FDA’s update completes the transition to full approval of the antiviral medication prescribed to treat mild-to-moderate COVID-19 in adults and children aged 12 and older weighing at least 40 pounds.

From Emergency Use to Full FDA Approval

Paxlovid, which contains the antiviral medications nirmatrelvir and ritonavir and was developed by Pfizer, first entered the market on Dec. 22, 2021, after the FDA issued an emergency use authorization (EUA) for the drug. The medication’s New Drug Application (NDA) was approved on May 25, 2023.

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