ASPR and FDA Statement on Shelf-Life Extension Evaluation of Lagevrio

June 14, 2023

The Administration for Strategic Preparedness and Response (ASPR) and the Food and Drug Administration (FDA) are announcing the authorization of an additional extension to the shelf life for the Merck antiviral therapy, Lagevrio (molnupiravir) capsules from 30 months to 36 months. Lagevrio capsules are currently authorized for emergency use for the treatment of mild-to-moderate COVID-19 in adults with positive results of direct SARS-CoV-2 viral testing who are at high risk for progressing to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate.

As a result of this extension, certain lots of Lagevrio capsules may be stored for an additional six or twelve months from the original labeled date of expiry (see Table 1 below). As required by the emergency use authorization, unopened cartons of Lagevrio capsules 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 Merck.

Please contact COVID19Therapeutics@hhs.gov with any questions.

Table 1: Extended Expiry Dating for Lagevrio Authorized under EUA 108