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Important Update

​Shelf-Life Extension of Etesevimab Under the Emergency Use Authorization for Bamlanivimab and Etesevimab Administered Together

October 22, 2021

Monoclonal Antibody Therapeutic Updates

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 Assistant Secretary for Preparedness and Response (ASPR) and the Food and Drug Administration (FDA) within the U.S. Department of Health and Human Services are committed to transparent communication regarding the COVID-19 monoclonal antibody treatments currently authorized for emergency use in certain patients with COVID-19.

FDA and ASPR are announcing the authorization of an extension to the shelf-life from 12 months to 18 months for the refrigerated Eli Lilly monoclonal antibody, etesevimab, which is currently authorized for emergency use only when administered together with bamlanivimab.  As a result of this extension, unopened vials of etesevimab, injection, 700 mg/20 mL, should be stored under refrigerated temperature at 2°C to 8°C (36°F to 46°F), and may be stored for an additional 6 months from the labeled date of expiry (See Table 1 below). FDA granted this extension following a thorough review of data submitted by Eli Lilly. This extension applies to all unopened vials of etesevimab that have been held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers and the Letter of Authorization for Emergency Use Authorization (EUA) 094 for bamlanivimab and etesevimab, administered together.

The etesevimab, authorized to be administered together with bamlanivimab under the EUA, has fixed expiration dates on the label of each vial and carton. The date identified on the vial and carton reflects the original shelf-life expiry of 12 months and does not reflect the extended 18-month shelf-life expiry. The table below provides the updated expiry, by batch, for distributed etesevimab.

Table 1: Extended Expiry Dating for Etesevimab Authorized under EUA 94 (Bamlanivimab and Etesevimab Administered together)

Batch Labeled Expiry Date Extended Expiry Date
D350991A 2021-12-06 2022-06-06
D351006A 2021-12-13 2022-06-13
D358393A 2022-01-10 2022-07-10
D366013E 2022-01-17 2022-07-17
D369838A 2022-01-24 2022-07-24
D352267A 2022-01-26 2022-07-26
D369838A 2022-01-24 2022-07-24
D349899A 2021-12-05 2022-06-05
D321280E 2021-10-08 2022-04-08
D396141A 2022-03-19 2022-09-19
D396144A 2022-03-16 2022-09-16
D396145A 2022-03-21 2022-09-21
D396147A 2022-03-22 2022-09-22
D396148A 2022-03-17 2022-09-17
D402425A 2022-04-09 2022-10-09
D397878A 2022-04-06 2022-10-06
D401742A 2022-04-16 2022-10-16
D401743A 2022-04-15 2022-10-15
D401744A 2022-04-16 2022-10-16
D401748A 2022-04-17 2022-10-17
D405856A 2022-04-18 2022-10-18
D405857A 2022-04-17 2022-10-17
D405862A 2022-04-17 2022-10-17
D408164A 2022-04-19 2022-10-19
D408165A 2022-04-19 2022-10-19
D411469A 2022-05-07 2022-11-07
D411470A 2022-05-07 2022-11-07
D411471A 2022-05-06 2022-11-06
D411472A 2022-05-07 2022-11-07
D412820A 2022-05-09 2022-11-09
D412821A 2022-05-08 2022-11-08
D412822A 2022-05-08 2022-11-08
D412823A 2022-05-08 2022-11-08
D417737A 2022-05-11 2022-11-11
D417739A 2022-05-11 2022-11-11
D417740A 2022-05-10 2022-11-10
D417741A 2022-05-10 2022-11-10
D418126A 2022-05-26 2022-11-26
D418127A 2022-05-26 2022-11-26