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FDA Approves Sanofi Pasteur’s Fluzone Vaccine

By Pharmaceutical Processing | December 15, 2014

Sanofi Pasteur, the vaccines division of Sanofi, has announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental biologics license application (sBLA) for Fluzone Intradermal Quadrivalent vaccine. Fluzone Intradermal vaccine, which has been available in trivalent formulation for three years, is now available in a quadrivalent formulation to help protect against four strains of influenza virus. Fluzone Intradermal Quadrivalent vaccine is indicated for adults 18 through 64 years of age for active immunization for the prevention of influenza (“the flu”) caused by influenza A subtype viruses and type B viruses contained in the vaccine.

“Influenza B is a common cause of influenza-related morbidity and mortality across all age groups,” said David P. Greenberg, M.D., Vice President, Scientific & Medical Affairs, and Chief Medical Officer, Sanofi Pasteur US. “Fluzone Intradermal Quadrivalent vaccine will offer another influenza vaccination option for health care providers and their adult patients with broad coverage against influenza viruses that may be predominant, coupled with the efficiency of using the intradermal microinjection system.”

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