Pandemics
Sanofi Pasteur Submits Supplemental Application for A(H1N1) Pandemic Vaccine to U.S. FDA
Published in TB and Outbreaks Week, August 18th, 2009
Sanofi Pasteur, the vaccines division of the sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), announced the company has submitted to the U.S. Food and Drug Administration (FDA) a supplemental application for licensure of its influenza A(H1N1) 2009 monovalent vaccine. Responding to recent recommendations by the FDA, the company's supplemental application requests the FDA's evaluation of the influenza A(H1N1) 2009 strain change, which is expected to expedite the licensure process for the pandemic vaccine.
"Filing this application is consistent with our commitment to work collaboratively with public health officials in producing a vaccine against the influenza A(H1N1)...
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