Posted by Michael Wonder on 12 May 2019
FDA approves prior approval supplement for Bivigam
10 May 2019 - ADMA Biologics announces that the U.S. FDA has approved the Company’s prior approval supplement for Bivigam (immune globulin intravenous (human), 10% liquid).
The FDA’s approval of the PAS for Bivigam approves the use of the Company’s optimised intravenous immune globulin manufacturing process and enables ADMA to commence the marketing of Bivigam in the U.S. to patients with primary humoral immunodeficiency.
