FDA Approves Baxter Healthcare's Gammagard Liquid 10 Percent

Baxter Healthcare Corporation announced recently that the U. S. Food and Drug Administration (FDA) has approved Gammagard Liquid [Immune Globulin Intravenous (Human)] (IGIV) 10 percent Solution for the treatment of primary immunodeficiency disorders associated with defects in humoral immunity. Primary immunodeficiency is a group of genetic disorders in which the immune system fails to produce adequate amounts of antibodies, thereby predisposing individuals to increased risk of infection. The company plans to launch the plasma-based therapy in the fourth quarter of this year.

The safety of Gammagard Liquid 10 percent has been demonstrated in a wide spectrum of patients with primary immunodeficiency disorders. Baxter produces the therapy using a three-step viral reduction process, a unique combination used to help ensure viral safety. Gammagard Liquid percent is free of added sugar, sodium and preservatives. In addition, the packaging is latex-free.