GSK SUBMITS APPLICATION FOR APPROVAL OF FLULAVAL

A A

GlaxoSmithKline (GSK) has submitted a biologics license application (BLA) for FluLaval (influenza virus vaccine) to the FDA. If licensed, FluLaval will be used for the active immunization of adults 18 years of age and older against influenza disease caused by influenza virus types A and B, which are contained in the vaccine.

FluLaval was granted fast-track status by the FDA in July 2005 and is marketed in Canada under the name Fluviral. If granted U.S. marketing approval for FluLaval, the company expects to provide up to 30 million doses of seasonal influenza vaccine (FluLaval and Fluarix) to the U.S. market for the 2006/2007 flu season.