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

August 20, 2021

Therapeutic Updates

The following stat​e​​ment is in addition to the shelf-life extension announcements from May 4, 2022; April 13, 2022; December 21, 2021; and October 22, 2021.

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 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, bamlanivimab, which is currently authorized for emergency use only when administered together with etesevimab.  As a result of this extension, unopened vials of bamlanivimab, 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 bamlanivimab 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 bamlanivimab authorized to be administered together with etesevimab 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 bamlanivimab.

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

Batch Labeled Expiry Date Extended Expiry Date
D308778A 2021-09-09 2022-03-09
D310126A 2021-09-27 2022-03-27
D318845A 2021-10-16 2022-04-16
D318846A 2021-10-23 2022-04-23
D2000176 2021-09-30 2022-03-30
D2000178 2021-10-31 2022-04-30
D2000180 2021-10-31 2022-04-30
D2000179 2021-10-31 2022-04-30
D308777C 2021-09-05 2022-03-05
D336348C 2021-11-01 2022-05-01
D340792A 2021-12-01 2022-06-01
D2000181 2021-10-31 2022-04-30
D332491A 2021-11-16 2022-05-16
D310125C 2021-09-22 2022-03-22
D2000193 2021-11-30 2022-05-30
D332490A 2021-11-21 2022-05-21
D347561A 2021-11-29 2022-05-29
D2000184 2021-11-30 2022-05-30
D332489A 2021-11-08 2022-05-08
D336908A 2021-11-19 2022-05-19
D2000183 2021-10-31 2022-04-30
D344776A 2021-11-22 2022-05-22
S20N002A 2021-12-14 2022-06-14
S20N001A 2021-12-02 2022-06-02
D336907A 2021-11-17 2022-05-17
S20N003A 2021-12-20 2022-06-20
D2000187 2021-11-30 2022-05-30
D2100021 2021-12-31 2022-06-30
D2000192 2021-12-31 2022-06-30
D2000186 2021-11-30 2022-05-30
D2000185 2021-11-30 2022-05-30
D2100022 2021-12-31 2022-06-30