Food and Drug Administration Approvals -- October 2003

Gamunex

(Immune Globulin Intravenous [Human], 10% by Chromatography Process)

Manufacturer: Bayer Corporation

Drug Approval Classification: Biologics License Application (Approval Date: 8/27/03)

Indication: Gamunex (immune globulin) is indicated for:

Primary humoral immunodeficiency (PI)
- Gamunex is indicated as replacement therapy of PI states in which severe impairment of antibody-forming capacity has been shown, such as congenital agammaglobulinemia, common variable immunodeficiency, X-linked immunodeficiency with hyper IgM, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.
Idiopathic thrombocytopenic purpura (ITP)
- Gamunex is indicated in ITP to rapidly raise platelet counts to prevent bleeding or to allow a patient with ITP to undergo surgery.