The US Food and Drug Administration (FDA) has approved GlaxoSmithKline's Flulaval Quadrivalent (Influenza Virus Vaccine) for the active immunization of people three years of age and more to help prevent disease caused by seasonal influenza (flu) virus subtypes A and B.
GSK's Fluarix Quadrivalent is the first-ever intramuscular influenza vaccine approved in December 2012 by the FDA and Flulaval Quadrivalent is the company's second intramuscular quadrivalent influenza vaccine cleared by the US regulator.
GSK Vaccines North America scientific affairs and public health director Dr Leonard Friedland said, "Trivalent vaccines do reduce influenza risk even in years when a vaccine strain-mismatch occurs, though quadrivalent influenza vaccines are the important next step in broadening strain coverage."
The approval allows GSK to supply substantial quantities of quadrivalent influenza vaccine shots in the US, which is manufactured in Quebec, Canada and Fluarix Quadrivalent manufactured in Dresden, Germany/Marietta.
While FluLaval Quadrivalent will be made available in multi-dose vials, Fluarix Quadrivalent is available in pre-filled syringes.