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

October 21, 2022

Therapeutics Update

The COVID-19 pandemic is rapidly evolving, and new updates are issued frequently. To view a full list of HHS/ASPR’s 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) announce the authorization of an extension to the shelf life for all lots of the Merck antiviral therapy, Lagevrio (molnupiravir) capsules from 24 to months to 30 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 months from the 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

Batch Number Labeled Batch
Expiry (24 Months)
New Expiry
(30 Months)
W001302 9-Feb-23 9-Aug-23
W001299 15-Feb-23 15-Aug-23
W001297 24-Feb-23 24-Aug-23
W001298 24-Feb-23 24-Aug-23
U038002 21-Mar-23 21-Sep-23
U036727 30-Mar-23 30-Sep-23
U036893 30-Mar-23 30-Sep-23
U036906 30-Mar-23 30-Sep-23
U038144 30-Mar-23 30-Sep-23
U036907 31-Mar-23 30-Sep-23
U038481 1-Apr-23 1-Oct-23
U038493 1-Apr-23 1-Oct-23
U038869 1-Apr-23 1-Oct-23
U039953 1-Apr-23 1-Oct-23
U038345 2-Apr-23 2-Oct-23
U039731 8-Apr-23 8-Oct-23
U037820 9-Apr-23 9-Oct-23
U038346 12-Apr-23 12-Oct-23
U039055 12-Apr-23 12-Oct-23
U039688 12-Apr-23 12-Oct-23
U038689 13-Apr-23 13-Oct-23
U039924 13-Apr-23 13-Oct-23
U038008 20-Apr-23 20-Oct-23
U038009 20-Apr-23 20-Oct-23
U038318 21-Apr-23 21-Oct-23
U039553 21-Apr-23 21-Oct-23
U039926 21-Apr-23 21-Oct-23
U039056 23-Apr-23 23-Oct-23
U038875 1-May-23 1-Nov-23
W001313 3-May-23 3-Nov-23
U039895 5-May-23 5-Nov-23
U039219 21-May-23 21-Nov-23
U039708 22-May-23 22-Nov-23
U039382 24-May-23 24-Nov-23
U040092 26-May-23 26-Nov-23
W000609 26-May-23 26-Nov-23
U040386 27-May-23 27-Nov-23
U039251 5-Jun-23 5-Dec-23
W000908 5-Jun-23 5-Dec-23
W001306 5-Jun-23 5-Dec-23
U039383 7-Jun-23 7-Dec-23
U039551 8-Jun-23 8-Dec-23
W000613 15-Jun-23 15-Dec-23
W000250 17-Jun-23 17-Dec-23
W000450 20-Jul-23 20-Jan-24
W002942 22-Jul-23 22-Jan-24
2587931 9-Aug-23 9-Feb-24
2587932 11-Aug-23 11-Feb-24
W001304 11-Aug-23 11-Feb-24
2587933 13-Aug-23 13-Feb-24
W000453 26-Aug-23 26-Feb-24
2587934 30-Aug-23 29-Feb-24
2587935 1-Sep-23 1-Mar-24
2587936 2-Sep-23 2-Mar-24
W001312 16-Sep-23 16-Mar-24
W001310 20-Sep-23 20-Mar-24
2662569 27-Sep-23 27-Mar-24
2666244 30-Sep-23 30-Mar-24
2664294 1-Oct-23 1-Apr-24
2666243 4-Oct-23 4-Apr-24
2666245 5-Oct-23 5-Apr-24
2664291 6-Oct-23 6-Apr-24
2664293 8-Oct-23 8-Apr-24
2669422 14-Oct-23 14-Apr-24
W002281 14-Oct-23 14-Apr-24
W002280 15-Oct-23 15-Apr-24
W002282 18-Oct-23 18-Apr-24
W002956 19-Oct-23 19-Apr-24
2669423 29-Oct-23 29-Apr-24
W003596 29-Oct-23 29-Apr-24