Sanofi Pasteur's new four-strain influenza vaccine application to be reviewed by FDA
Oct 19, 2012 (Menafn - M2 EQUITYBITES via COMTEX) --Sanofi Pasteur, the vaccines division of healthcare company Sanofi SNY, announced on Thursday that it has filed a Supplemental Biologics License Application (sBLA) with the US Food and Drug Administration (FDA) for a quadrivalent formulation of its Fluzone (Influenza Virus Vaccine).
The company said that the sBLA file has been accepted by the FDA for full review and an action date is anticipated in the second quarter of 2013.
The strains for each season's influenza vaccine are selected by the FDA, in consultation with global health authorities, from the strains anticipated to circulate in the approaching influenza season.
Sanofi Pasteur said that it is seeking FDA licensure of Fluzone Quadrivalent Influenza Virus Vaccine for active immunization of children and adults six months of age and older 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 Sanofi Pasteur's currently licensed trivalent influenza virus vaccine, Fluzone vaccine, which according to the company is the only influenza vaccine licensed in the US for children as young as six months of age.
If approved by the FDA, Fluzone Quadrivalent vaccine would be the first quadrivalent influenza vaccine for Sanofi Pasteur. Sanofi Pasteur also has development efforts underway for quadrivalent formulations of the company's other influenza vaccines, including Fluzone High-Dose and Fluzone Intradermal vaccines, which are marketed in the US, and Vaxigrip vaccine, which is marketed outside the US.
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