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Cangene vaccinia immune globulin I.V. approved

Executive Summary

FDA grants accelerated approval for Cangene's CNJ-016 (vaccinia immune globulin intravenous) for the treatment of smallpox vaccination complications May 3. It is the second VIGIV biologics license application granted accelerated approval; the agency approved DynPort's VIGIV Feb. 18. Both approvals were based on limited pharmacokinetic and pharmacodynamic data and require the sponsors to conduct confirmatory trials. Cangene developed the product under a 2002 contract with the Centers for Disease Control & Prevention. The contract allows CDC to order a total of up to 100,000 doses through 2007...

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