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www.fdanews.com/articles/89837-gsk-s-relenza-approved-in-canada-for-preventing-flu

GSK'S RELENZA APPROVED IN CANADA FOR PREVENTING FLU

January 8, 2007

GlaxoSmithKline (GSK) announced it has received approval from Health Canada for use of its antiviral Relenza (zanamivir) dry powder for inhalation for the prevention of influenza in adults and children 7 years of age and older.

Relenza was already approved in Canada for treating existing cases of influenza A and B in adults and children 7 years and older.

The drug won U.S. approval for the prevention of influenza in adults and children in March 2006, and is similarly approved in 15 European countries, according to GSK. Relenza is also approved in the U.S. for treating existing cases of influenza in adults and children 7 years and older, and in Europe for the treatment of influenza in adults and children 5 years and older.

Recently Biota, which manufactures the drug for GSK, announced that the Canadian government planned to increase its stockpile of Relenza to 5.5 million courses.

"As Canada's leading seasonal flu vaccine manufacturer, GSK is committed to supporting governments and health authorities -- both across Canada and around the world -- in planning to respond to a global influenza pandemic," Paul Lucas, GSK president and CEO, said.