Trade Resources Industry Views US FDA Has Approved Cangene's Varizig for Post-Exposure Prophylaxis of Varicella

US FDA Has Approved Cangene's Varizig for Post-Exposure Prophylaxis of Varicella

The US FDA has approved Cangene's Varizig for post-exposure prophylaxis of varicella in patients including immunocompromised children, newborns and pregnant women.

The hyperimmune product that contains antibodies specific for the Varicella zoster virus is intended to reduce the severity of chickenpox infections in the patients.

Cangene president and chief executive officer John Sedor said, "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."

Varicella Zoster Immune Globulin (Human) was cleared in Canada and was previously made available in the US under an investigational new drug (IND) Expanded Access Protocol.

The product is expected to be available for distribution by FFF Enterprises in March 2013 until which Expanded Access Protocol will remain active.

Source: http://regulatoryaffairs.pharmaceutical-business-review.com/news/fda-approves-cangene-varizig-090113
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FDA Approves Cangene Varizig