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

June 27, 2022

Therapeutic Updates

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.

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 Vialsb

Vial Batch Numbera Labelled Expiry Date Extended Expiry Date
8363700003c 31-Aug-2022 28-Feb-2023
8363700004c 31-Aug-2022 28-Feb-2023
8363700005 31-Aug-2022 28-Feb-2023
8363700006 30-Sep-2022 31-Mar-2023
8363700008 30-Sep-2022 31-Mar-2023
8363700007 30-Sep-2022 31-Mar-2023
8364900002c 30-Jun-2022 31-Dec-2022
8364900005c 31-Jul-2022 31-Jan-2023
8364900006c 31-Aug-2022 28-Feb-2023
8391600002 31-Oct-2022 30-Apr-2023
8391600001 31-Oct-2022 30-Apr-2023
8391600003 31-Oct-2022 30-Apr-2023
8391600004 31-Dec-2022 30-Jun-2023
8391600005 31-Dec-2022 30-Jun-2023
8391600006 31-Dec-2022 30-Jun-2023

Table 1b: Individually Cartoned Imdevimab Vialsb

Vial Batch Numbera Labelled Expiry Date Extended Expiry Date
8364300003c 31-Aug-2022 28-Feb-2023
8364300004c 31-Aug-2022 28-Feb-2023
8364300005 31-Aug-2022 28-Feb-2023
8364300008 30-Sep-2022 31-Mar-2023
8364300007 30-Sep-2022 31-Mar-2023
8364300006 30-Sep-2022 31-Mar-2023
8364300011 30-Sep-2022 31-Mar-2023
8364300010 31-Oct-2022 30-Apr-2023
8364300009 31-Oct-2022 30-Apr-2023
8365500002c 30-Jun-2022 31-Dec-2022
8365500004c 31-Jul-2022 31-Jan-2023
8390800002 31-Oct-2022 30-Apr-2023
8390800003 31-Oct-2022 30-Apr-2023
8390800001 31-Oct-2022 30-Apr-2023
8390800004 31-Dec-2022 30-Jun-2023
8390800005 31-Dec-2022 30-Jun-2023
8390800006 31-Mar-2023 30-Sep-2023
8390800007 31-Mar-2023 30-Sep-2023

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

Dose-pack Batch Number Labelled Expiry Date a Extended Expiry Date a
8409400029 30-Jun-22 31-Dec-22
8409400031 30-Jun-22 31-Dec-22
8409600003 30-Jun-22 31-Dec-22
8409400026 31-Jul-22 31-Jan-23
8409600001 31-Jul-22 31-Jan-23
8409600002 31-Jul-22 31-Jan-23
8409500006 31-Aug-22 28-Feb-23
8409500001 30-Sep-22 31-Mar-23
8409500002 30-Sep-22 31-Mar-23
8409500003 30-Sep-22 31-Mar-23
8409500004 30-Sep-22 31-Mar-23
8409500005 30-Sep-22 31-Mar-23
8409500007 30-Sep-22 31-Mar-23
8409400001 31-Oct-22 30-Apr-23
8409400002 31-Oct-22 30-Apr-23
8409400003 31-Oct-22 30-Apr-23
8409400005 31-Oct-22 30-Apr-23
8409400006 31-Oct-22 30-Apr-23
8409400007 31-Oct-22 30-Apr-23
8409400008 31-Oct-22 30-Apr-23
8409400009 31-Oct-22 30-Apr-23
8409400010 31-Oct-22 30-Apr-23
8409400011 31-Oct-22 30-Apr-23
8409400012 31-Oct-22 30-Apr-23
8409400013 31-Oct-22 30-Apr-23
8409400014 31-Oct-22 30-Apr-23
8409400015 31-Oct-22 30-Apr-23
8409400016 31-Oct-22 30-Apr-23
8409400017 31-Oct-22 30-Apr-23
8409400018 31-Oct-22 30-Apr-23
8409400019 31-Oct-22 30-Apr-23
8409400020 31-Oct-22 30-Apr-23
8409400021 31-Oct-22 30-Apr-23
8409400022 31-Oct-22 30-Apr-23
8409400023 31-Dec-22 30-Jun-23
8409400024 31-Dec-22 30-Jun-23
8409400025 31-Dec-22 30-Jun-23
8409400027 31-Dec-22 30-Jun-23
8409400028 31-Dec-22 30-Jun-23
8409400032 31-Dec-22 30-Jun-23
8409400033 31-Dec-22 30-Jun-23

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

Batch Numbera Labelled Expiry Date Extended Expiry Date
N7561B05 Dec 2022 Jun 2023
N7568B03 Dec 2022 Jun 2023
N7561B03 Dec 2022 Jun 2023
N7568B01 Dec 2022 Jun 2023
N7568B02 Dec 2022 Jun 2023
N7578B05 May 2023 Nov 2023
N7578B06 May 2023 Nov 2023
N7561B02 Dec 2022 Jun 2023
N7561B04 Dec 2022 Jun 2023
N7568B04 Dec 2022 Jun 2023
N7567B04 Apr 2023 Oct 2023
N7589B01 Jun 2023 Dec 2023
N7589B02 Jun 2023 Dec 2023
N7606B02 Jun 2023 Dec 2023
N7589B03 Jun 2023 Dec 2023
N7582B01 May 2023 Nov 2023
N7582B02 May 2023 Nov 2023
N7589B04 Jun 2023 Dec 2023
N7601B01 Jun 2023 Dec 2023
N7601B02 Jun 2023 Dec 2023
N7601B03 Jun 2023 Dec 2023

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

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