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

December 21, 2021

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*

*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*