U.S. FDA approves Cangene's anti-hepatitis B product
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Cangene announced that the U.S. food and Drug Administration (FDA) has approved Cangene's HepaGam B(TM) for treatment following acute exposure to hepatitis B virus. HepaGam B(TM) is Cangene's hepatitis B immune globulin (human), a purified antibody or hyperimmune that is specific for the hepatitis B virus.
Cangene manufactures HepaGam B(TM) in its Winnipeg facility using a process similar to that of WinRho(R) SDF and Vaccinia immune globulin, the Company's earlier FDA-approved drugs. The Company anticipates that the drug will be distributed in the U.S. by Apotex Corp., a member of the Apotex Group, Cangene's majority shareholder. The companies expect to launch the product within the next few months.