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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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