Shelf-Life Extension of Bebtelovimab Authorized: 18 months to 24 months

October 28, 2022

The Administration for Strategic Preparedness and Response (ASPR) and the Food and Drug Administration (FDA) are announcing the authorization of an additional extension to the shelf life from 18 months to 24 months for specific lots of the refrigerated Eli Lilly monoclonal antibody, bebtelovimab, which is currently authorized for emergency use.

As a result of this extension, some batches may be stored for an additional 6 months from the labeled date of expiry (see Table 1 below) and, as required by the emergency use authorization for bebtelovimab, unopened vials of bebtelovimab injection, 175 mg/2 mL, must be stored under refrigerated temperature at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. FDA granted this extension following a thorough review of data submitted by Eli Lilly. This extension applies to all unopened vials of bebtelovimab 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) 111 for bebtelovimab.

Bebtelovimab 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 a list of the updated expiry, by batch, for distributed bebtelovimab. 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 Bebtelovimab Authorized under EUA 111