Biotest Pharmaceuticals announced that the FDA has approved Bivigam (immune globulin intravenous [human], 10%) liquid with a validated assay for measuring thrombogenic activity. Bivigam is a sugar-free, glycine stabilized, polyspecific intravenous immune globulin (IVIG) for the treatment of patients with primary humoral immunodeficiency (PI).

Bivigam is the first FDA-approved IVIG with a thrombin generation assay test. These tests are utilized to detect procoagulant activity in efforts to reduce the risk of thromboembolic events.  Every lot of Bivigam will be screened before release to assure that it fulfills the criteria pertaining to the Factor XIa threshold levels.

Bivigam is available in a 10% liquid in 50mL and 100mL tamper-evident vials. Biotest Pharmaceuticals plans to ship this product shortly.

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