Health Canada Approves Cangene Corporation's Anti-Hepatitis B product

TORONTO and WINNIPEG, Jan. 22 /CNW/ - Cangene today announces that it has received a Notice of Compliance with conditions ("NOC/c") for its HepaGam B(TM) hyperimmune product from the Biologics and Genetic Therapies Directorate of Health Canada. The approved indication is for the prevention of Hepatitis B recurrence following liver transplantation in adult patients with Hepatitis B who have no or low levels of hepatitis B virus replication. This NOC/c confers marketing approval to the drug in Canada while requiring the Company to continue with a confirmatory clinical study. HepaGam B(TM) is Cangene's Hepatitis B Immune Globulin (human) Injection, which is a purified antibody or hyperimmune that is specific for the hepatitis B virus. It is the only intravenous product licensed in Canada for this indication. An NOC/c is granted to provide patients who are suffering from serious, life-threatening or severely debilitating illnesses or conditions, accelerated access to promising new therapies.

Back to news