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Cangene’s HepaGam B Approved for New Indication

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Cangene Corp. received approval from the FDA for HepaGam B for the prevention of hepatitis B recurrence following liver transplantation in hepatitis B surface antigen (HBsAg)-positive patients. HepaGam B is Cangene’s Hepatitis B Immune Globulin Intravenous, which is a purified antibody or hyperimmune that is specific for the hepatitis B virus. Clinical data showed HepaGam B was highly effective at preventing hepatitis B recurrence and the dosing regimen used demonstrated anti-HBsAg levels ...

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