FDA Authorizes Shelf Life Extension for Certain Lots of Paxlovid

September 6, 2022

The COVID-19 pandemic is rapidly evolving, and new updates are issued frequently. To view a full list of HHS/ASPRs updates related to COVID-19 monoclonal antibody therapeutics, please see our full list of updates.

The Administration for Strategic Preparedness and Response (ASPR) and the Food and Drug Administration (FDA) announces the authorization of an extension to the shelf life from 12 months to 18 months for certain lots of the Pfizer antiviral therapy, Paxlovid (nirmatrelvir tablets and ritonavir tablets co-packaged for oral use), which is currently authorized for emergency use for the treatment of mild-to-moderate COVID-19 in certain adults and pediatric patients (12 years of age and older weighing at least 40kg).

As a result of this extension, lots of Paxlovid with dates of expiry from July 2022 to May 2023 may be stored for an additional six months from the labeled date of expiry (see Table 1 below). As required by the emergency use authorization, unopened cartons of Paxlovid (300 mg nirmatrelvir and 100 mg ritonavir, or 150 mg nirmatrelvir and 100 mg ritonavir), must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers. FDA granted this extension following a thorough review of data submitted by Pfizer.

Please contact COVID19Therapeutics@hhs.gov with any questions.

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FDA Authorizes Shelf Life Extension for Certain Lots of Paxlovid