The Food and Drug Administration (FDA) has approved an extended shelf life for both Asceniv™ (immune globulin intravenous [human] – slra) 10% Liquid and Bivigam® (immune globulin intravenous [human]) 10% Liquid from 24 to 36 months stored at 2 to 8°C (36°F to 46°F).
The extended expiration date for Asceniv and Bivigam is immediately effective and applies to all existing lots currently in the commercial supply chain and to future production in all vial sizes, production scales as well as internal and external fill-finished drug products.
Asceniv and Bivigam are indicated for the treatment of primary humoral immunodeficiency in adults and adolescents (12 to 17 years of age). Primary immunodeficiency includes, but is not limited to, the humoral immune defect in common variable immunodeficiency, X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.
Asceniv is supplied as a liquid solution containing 10% IgG (100mg/mL) in a 50mL single-use vial. Bivigam is supplied as a liquid solution containing 10% IgG (100mg/mL) in a 50mL and 100mL single-use vial.
ADMA Biologics announces FDA approval of extended shelf life for Asceniv™ & Bivigam® from 24 to 36 months. News release. ADMA Biologics, Inc. March 25, 2022. Accessed March 29, 2022. https://www.globenewswire.com/news-release/2022/03/25/2410129/33130/en/ADMA-Biologics-Announces-FDA-Approval-of-Extended-Shelf-Life-for-ASCENIV-BIVIGAM-from-24-to-36-Months.html