ADMA Biologics announces commercial relaunch of BIVIGAM
ADMA Biologics announces the commercial relaunch and its first commercial sales of BIVIGA. As previously reported, BIVIGAM had a Biologics License Application manufacturing change Prior Approval Supplement approved by the United States Food and Drug Administration on May 9, 2019, enabling ADMA to resume marketing BIVIGAM to US- based prescribers and healthcare professionals. BIVIGAM is approved for the treatment of patients diagnosed with primary humoral immunodeficiency. This includes, but is not limited to, the humoral immune defect in common variable immunodeficieny, X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.