Cangene Corporation has announced that the United States Food and Drug Administration has approved VARIZIG® [Varicella Zoster Immune Globulin (Human)] for post-exposure prophylaxis of varicella (chickenpox) in high risk patient groups including immunocompromised children, newborns and pregnant women.
VARIZIG is intended to reduce the severity of chickenpox infections in these patients.
VARIZIG is a hyperimmune product that contains antibodies specific for the Varicella zoster virus which causes the viral infection known as chickenpox.
VARIZIG is approved in Canada and was previously made available in the United States under an investigational new drug (IND) Expanded Access Protocol.
Through the expanded access program, VARIZIG was available for patients at risk of severe complications of varicella, to address the unmet need in this population.
The Expanded Access Protocol will remain active until commercial product is available for distribution which is expected in early March of 2013.
VARIZIG will continue to be distributed exclusively by FFF Enterprises, Inc., a leading biopharmaceutical supplier.
"The approval of VARIZIG in the United States marks an important milestone in Cangene's history" says John A. Sedor, President and Chief Executive Officer of Cangene.
"While VARIZIG services a small niche infectious disease market, the approval of the product in the United States adds a fourth product to our commercial portfolio and reflects our patient focused strategy by addressing an ongoing medical need" added Mr. Sedor.