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FDA Authorizes Sh​elf-Life Extension for Bamlanivimab From 18 to 24 Months

May 4, 2022

Therapeutics Update

The following state​​​ment is in addition to the shelf-life extension announcements from April 13, 2022;December 21, 2021; October 22, 2021; and August 20, 2021.


The COVID-19 pandemi​c 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 have issued joint communications regarding the availability of COVID-19 monoclonal antibody treatments currently authorized for emergency use in certain patients with COVID-19.

On May 4, 2022, FDA authorized an extension to the shelf-life from 18 months to 24 months for specific lots of the refrigerated Eli Lilly monoclonal antibody, bamlanivimab (see Table 1 below). Due to the high frequency of the Omicron variant, bamlanivimab and etesevimab are not currently authorized in any U.S. region. Therefore, these drugs may not be administered for treatment or post-exposure prevention of COVID-19 under the Emergency Use Authorization until further notice by the Agency. However, it is the recommendation of the U.S. Government that product be retained in the event that future SARS-CoV-2 variants, which may be susceptible to bamlanivimab and etesevimab, emerge and become prevalent in the United States. Retained product must be appropriately 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.

Evaluation of future extension of shelf-life for etesevimab is ongoing and an update regarding shelf-life extension for etesevimab is planned for November 2022. Therefore, in the interim, all etesevimab vials may be retained until the shelf-life extension evaluation is complete and posted, regardless of the current labeled expiry date or previously provided extension dates.

These recommendations apply to all unopened vials of bamlanivimab and etesevimab that have been held in accordance with storage conditions (refrigerated temperature at 2°C to 8°C (36°F to 46°F)) detailed in the authorized Fact Sheet for Health Care Providers or EUA 094 for bamlanivimab and etesevimab, administered together. Please contact COVID19Therapeutics@hhs.gov with any questions.

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

Batch Labelled Expiry Date Extended Expiry Date
D308777C 2021-09-05 2022-09-05
D308778A 2021-09-09 2022-09-09
D310125C 2021-09-22 2022-09-22
D310126A 2021-09-27 2022-09-27
D2000176 2021-09-30 2022-09-30
D318845A 2021-10-16 2022-10-16
D318846A 2021-10-23 2022-10-23
D2000178 2021-10-31 2022-10-31
D2000179 2021-10-31 2022-10-31
D2000180 2021-10-31 2022-10-31
D2000181 2021-10-31 2022-10-31
D2000183 2021-10-31 2022-10-31
D336348C 2021-11-01 2022-11-01
D332489A 2021-11-08 2022-11-08
D332491A 2021-11-16 2022-11-16
D336907A 2021-11-17 2022-11-17
D336908A 2021-11-19 2022-11-19
D332490A 2021-11-21 2022-11-21
D344776A 2021-11-22 2022-11-22
D347561A 2021-11-29 2022-11-29
D2000184 2021-11-30 2022-11-30
D2000185 2021-11-30 2022-11-30
D2000186 2021-11-30 2022-11-30
D2000187 2021-11-30 2022-11-30
D2000193 2021-11-30 2022-11-30
D340792A 2021-12-01 2022-12-01
S20N001A 2021-12-02 2022-12-02
S20N002A 2021-12-14 2022-12-14
S20N003A 2021-12-20 2022-12-20
D2000192 2021-12-31 2022-12-31
D2100021 2021-12-31 2022-12-31
D2100022 2021-12-31 2022-12-31
D2100023 2021-12-31 2022-12-31
D2100024 2021-12-31 2022-12-31
D2100058 2021-12-31 2022-12-31
S21A021C 2022-01-24 2023-01-24
D2100026 2022-01-31 2023-01-31
D2100027 2022-01-31 2023-01-31
D2100028 2022-01-31 2023-01-31
D2100036 2022-01-31 2023-01-31
D2100037 2022-01-31 2023-01-31
S21B001A 2022-01-31 2023-01-31
S21B003A 2022-02-10 2023-02-10
S21C017A 2022-09-12 2023-03-12
S21C018A 2022-09-15 2023-03-15
S21D001A 2022-10-05 2023-04-05
D2100038 2022-11-22 2023-05-22
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