GSK'S SEASONAL FLU VACCINE FLULAVAL APPROVED BY FDA

UK-based GlaxoSmithKline (GSK) announced that the FDA has approved its FluLaval influenza vaccine for the active immunization of adults 18 years and older against flu caused by influenza virus types A and B.

GSK added FluLaval to its portfolio of flu products when it acquired the Canadian vaccine manufacturer ID Biomedical last year. FluLaval, which will be available in packages of 10 dose multidose vials, was granted fast-track review status by the FDA. It is marketed in Canada under the name Fluviral.

The FDA reviewed data from clinical trials that studied FluLaval in 1,000 healthy adults ages 18 to 64 in the United States and in 658 subjects 50 and older in Canada. The results of the randomized, controlled, comparative trials showed FluLaval to be safe and to stimulate an immune response. The vaccine's indication is based on immune response elicited by FluLaval, and there have been no controlled trials demonstrating a decrease in influenza disease after vaccination with FluLaval. FluLaval is not indicated for use in children.