Green Cross announced that it has submitted its Biologics License Application (BLA) to the Food and Drug Administration (FDA) for IVIG-SN (human normal immunoglobulin G) for the treatment of primary immunodeficiency diseases (PID).

The submission is based on positive results from a Phase 3 study which demonstrated that IVIG-SN met its primary endpoint of no acute bacterial infections in patients with PID. These results were well under the FDA requirement of no more than 1 acute serious bacterial infection per patient-year.

RELATED: Immune Disorders Resource Center

Green Cross has been marketing IVIG-SN in more than 30 countries in Asia, South America and Middle East. 

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