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Published on 1/30/2006 in the Prospect News Biotech Daily.

Cangene gets FDA approval for HepaGam B for hepatitis B

New York, Jan. 30 - Cangene said the Food and Drug Administration approved its HepaGam B for treatment following acute exposure to hepatitis B virus.

HepaGam B is Cangene's hepatitis B immune globulin (human), a purified antibody or hyperimmune that is specific for the hepatitis B virus. Hepatitis B is a highly infectious virus that can be spread through contact with blood and other bodily fluids from an infected person or can be transmitted from an infected mother to a newborn during birth.

Cangene expects the drug will be launched in the next few months and to be distributed in the United States by Apotex Corp., a member of the Apotex Group, Cangene's majority shareholder.

"This is Cangene's fourth approved drug and the third drug to receive FDA approval - a significant accomplishment for a biopharmaceutical company. The depth of our hyperimmune program keeps growing, as does our international reputation," said John Langstaff, Cangene's president and chief executive officer, in a news release.

Cangene is a Winnipeg, Manitoba-based biotechnology company.


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