sBLA Accepted for Fluzone Quadrivalent Influenza Virus Vaccine
Sanofi Pasteur, the vaccines division of Sanofi, announced that it has filed a Supplemental Biologics License Application (sBLA) with the FDA for a quadrivalent formulation of its Fluzone (Influenza Virus Vaccine); the sBLA file has been accepted by the FDA for full review, and an action date is anticipated in the second quarter of 2013.
Sanofi Pasteur is seeking FDA licensure of Fluzone Quadrivalent Influenza Virus Vaccine for active immunization of children and adults ≥6 months of age for the prevention of influenza disease caused by influenza virus subtypes A and types B contained in the vaccine. This is the same age indication for the currently licensed trivalent Fluzone influenza virus vaccine.
For more information call (800) VACCINE or visit www.sanofipasteur.us.