GSK submits Flulaval BLA to US FDA

UK-based GlaxoSmithKline, the world's second-largest drugmaker, has submitted a Biologics License Application for FluLaval (influenza virus vaccine) to the US Food and Drug Administration. If licensed, the product will be used for the active immunization of adults 18 years of age and older against disease caused by influenza virus types A and B, which are contained in the vaccine.

GSK added FluLaval to its portfolio of flu products when it acquired the Canadian vaccine manufacturer ID Biomedical Corp last year (Marketletter December 19, 2005). The agent was granted fast-track status by the FDA and is marketed in Canada as Fluviral. If it is approved, GSK expects to provide up to 30 million doses of seasonal influenza vaccine (FluLaval and Fluarix) for the 2006/2007 US flu season.