FDA Authorizes Shelf-Life Extension for REGEN‑COV From 24 months to 30 Months

June 27, 2022

On June 27, 2022, FDA authorized an extension to the shelf-life from 24 months to 30 months for specific lots of the refrigerated Regeneron monoclonal antibodies, casirivimab and imdevimab, administered together or REGEN-COV (see Table 1, Table 2, and Table 3 below). Due to the high frequency of the Omicron variant and its subvariants, REGEN-COV is not currently authorized in any U.S. region. Therefore, REGEN-COV 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 REGEN-COV, 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) 091.

These recommendations apply to all unopened vials of casirivimab, imdevimab, and REGEN-COV 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 for EUA 091 for casirivimab and imdevimab, administered together. Please contact COVID19Therapeutics@hhs.gov with any questions.

Table 1: Extended Expiry Dating for Individually Cartoned Vials of Casirivimab and Imdevimab (REGEN-COV) Authorized under EUA 91

Table 1a: Individually Cartoned Casirivimab Vials^b

Table 1b: Individually Cartoned Imdevimab Vials^b

^aBatch number represents the number printed on the vial for individually cartoned and dose-packed casirivimab and imdevimab.

^bSome of the batches provided as individually cartoned vials were also included in dose-packs. Expiration date for dose-packs is based on the shortest expiry of all individually cartoned vials included in the dose-pack.

^cExpiration date not printed on the carton.

Table 2: Extended Expiry Dating for Dose-Packed REGEN-COV Authorized under EUA 91

^aExpiration date for dose-packs is based on the shortest expiry of all individually cartoned vials included in the dose-pack.

Table 3: Extended Expiry Dating for Co-packaged REGEN-COV Authorized under EUA 91

^aFor co-packaged material, the batch number represents the number printed on the carton