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

December 21, 2021

Therapeutics Update

The following state​​m​ent is in addition to the shelf-life extension announcements from May 4, 2022; April 13, 2022; October 22, 2021; and August 20, 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 specific lots of the refrigerated Eli Lilly monoclonal antibodies, bamlanivimab and etesevimab, which are currently authorized for emergency use only when administered together. This announcement provides a cumulative listing of all batches authorized for shelf-life extension, including batches previously authorized for shelf-life extension for bamlanivimab on August 20, 2021 and for etesevimab on October 22, 2021.

As a result of this extension, unopened vials of bamlanivimab and 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 and Table 2 below). FDA granted this extension following a thorough review of data submitted by Eli Lilly. This extension applies to all unopened vials of bamlanivimab and 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 bamlanivimab and etesevimab, authorized to be administered together 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 tables below provide a cumulative list of the updated expiry, by batch, for distributed bamlanivimab and etesevimab. If the batch number on the vial/carton is not included in this listing, the product is labeled with the correct expiration date.

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

Batch Labeled Expiry Date Extended Expiry Date
D308777C 2021-09-05 2022-03-05
D308778A 2021-09-09 2022-03-09
D310125C 2021-09-22 2022-03-22
D310126A 2021-09-27 2022-03-27
D2000176 2021-09-30 2022-03-30
D318845A 2021-10-16 2022-04-16
D318846A 2021-10-23 2022-04-23
D2000178 2021-10-31 2022-04-30
D2000180 2021-10-31 2022-04-30
D2000179 2021-10-31 2022-04-30
D2000181 2021-10-31 2022-04-30
D2000183 2021-10-31 2022-04-30
D336348C 2021-11-01 2022-05-01
D332489A 2021-11-08 2022-05-08
D332491A 2021-11-16 2022-05-16
D336907A 2021-11-17 2022-05-17
D336908A 2021-11-19 2022-05-19
D332490A 2021-11-21 2022-05-21
D344776A 2021-11-22 2022-05-22
D347561A 2021-11-29 2022-05-29
D2000193 2021-11-30 2022-05-30
D2000184 2021-11-30 2022-05-30
D2000187 2021-11-30 2022-05-30
D2000186 2021-11-30 2022-05-30
D2000185 2021-11-30 2022-05-30
D340792A 2021-12-01 2022-06-01
S20N001A 2021-12-02 2022-06-02
S20N002A 2021-12-14 2022-06-14
S20N003A 2021-12-20 2022-06-20
D2100021 2021-12-31 2022-06-30
D2000192 2021-12-31 2022-06-30
D2100022 2021-12-31 2022-06-30
D2100058 2021-12-31 2022-06-30
D2100023 2021-12-31 2022-06-30
D2100024 2021-12-31 2022-06-30
S21A021C 2022-01-24 2022-07-24
S21B001A 2022-01-31 2022-07-31
D2100026 2022-01-31 2022-07-31
D2100027 2022-01-31 2022-07-31
D2100028 2022-01-31 2022-07-31
D2100036 2022-01-31 2022-07-31
D2100037 2022-01-31 2022-07-31
S21B003A 2022-02-10 2022-08-10

*If the batch number on the vial/carton is not included in this listing, the product is labeled with the correct expiration date.

Table 2: Extended Expiry Dating for Etesevimab Authorized under EUA 94 (Bamlanivimab and Etesevimab Administered together)- Cumulative Listing*

Batch Labeled Expiry Date Extended Expiry Date
D321280E 2021-10-08 2022-04-08
D349899A 2021-12-05 2022-06-05
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
D352266C 2022-01-22 2022-07-22
D369838A 2022-01-24 2022-07-24
D352267A 2022-01-26 2022-07-26
D396144A 2022-03-16 2022-09-16
D396148A 2022-03-17 2022-09-17
D396141A 2022-03-19 2022-09-19
D396145A 2022-03-21 2022-09-21
D396147A 2022-03-22 2022-09-22
D397878A 2022-04-06 2022-10-06
D398677A 2022-04-07 2022-10-07
D402425A 2022-04-09 2022-10-09
D401743A 2022-04-15 2022-10-15
D401742A 2022-04-16 2022-10-16
D401744A 2022-04-16 2022-10-16
D405865A 2022-04-16 2022-10-16
D401748A 2022-04-17 2022-10-17
D405857A 2022-04-17 2022-10-17
D405862A 2022-04-17 2022-10-17
D405856A 2022-04-18 2022-10-18
D408236A 2022-04-18 2022-10-18
D408164A 2022-04-19 2022-10-19
D408165A 2022-04-19 2022-10-19
D411471A 2022-05-06 2022-11-06
D411469A 2022-05-07 2022-11-07
D411470A 2022-05-07 2022-11-07
D411472A 2022-05-07 2022-11-07
D412821A 2022-05-08 2022-11-08
D412822A 2022-05-08 2022-11-08
D412823A 2022-05-08 2022-11-08
D412820A 2022-05-09 2022-11-09
D417740A 2022-05-10 2022-11-10
D417741A 2022-05-10 2022-11-10
D417737A 2022-05-11 2022-11-11
D417739A 2022-05-11 2022-11-11
D418126A 2022-05-26 2022-11-26
D418127A 2022-05-26 2022-11-26
D418128A 2022-05-27 2022-11-27
D418129A 2022-05-27 2022-11-27
D418130A 2022-05-28 2022-11-28
D418132A 2022-05-28 2022-11-28
D418133A 2022-05-29 2022-11-29
D418134A 2022-05-29 2022-11-29
D419718A 2022-05-30 2022-11-30
D419719A 2022-05-31 2022-11-30
D422799A 2022-06-04 2022-12-04
D422801A 2022-06-05 2022-12-05
D422798A 2022-06-07 2022-12-07
D427700A 2022-06-07 2022-12-07
D427706A 2022-06-08 2022-12-08
D457961 2022-06-09 2022-12-09
D457963 2022-06-14 2022-12-14
D457949 2022-07-30 2023-01-30
D457948 2022-07-31 2023-01-31
D457962 2022-07-31 2023-01-31
D454628 2022-08-01 2023-02-01
D455062 2022-08-01 2023-02-01
D454627 2022-08-02 2023-02-02
D454625 2022-08-03 2023-02-03
D455061 2022-08-04 2023-02-04
D454055 2022-08-05 2023-02-05
D457964 2022-08-05 2023-02-05
D454052 2022-08-06 2023-02-06
D454054 2022-08-06 2023-02-06
D454053 2022-08-06 2023-02-06
D453505 2022-08-07 2023-02-07
D453502 2022-08-07 2023-02-07
D457950 2022-08-23 2023-02-23
D452234 2022-08-24 2023-02-24
D453506 2022-08-24 2023-02-24
D453507 2022-08-24 2023-02-24
D452236 2022-08-25 2023-02-25
D452237 2022-08-25 2023-02-25

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