LYON, France and SWIFTWATER, Pa., Aug. 7 /PRNewswire/ -- Sanofi Pasteur, the vaccines division of the sanofi-aventis Group , announced today 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.
The supplemental application follows recent recommendations by the FDA to evaluate the influenza A(H1N1) 2009 monovalent vaccines using the same regulatory process by which it approves new viral strains contained in the annual seasonal influenza vaccines. Sanofi Pasteur's influenza A(H1N1) 2009 monovalent vaccine supplemental application specifies the evaluation of a non-adjuvanted vaccine.
About sanofi-aventis
Sanofi Pasteur, the vaccines division of sanofi-aventis Group, provided more than 1.6 billion doses of vaccine in 2008, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, Sanofi Pasteur offers the broadest range of vaccines protecting against 20 infectious diseases. The company's heritage, to create vaccines that protect life, dates back more than a century. Sanofi Pasteur is the largest company entirely dedicated to vaccines. Every day, the company invests more than EUR 1 million in research and development. For more information, please visit: www.sanofipasteur.com or www.sanofipasteur.us.
Forward Looking Statements
Contacts
SOURCE Sanofi Pasteur
CONTACT: Global Media Relations, Pascal Barollier, +33-(0)4-37-37-50-38,
pascal.barollier@sanofipasteur.com; or US Media Relations, Donna Cary,
+1-570-957-0717, donna.cary@sanofipasteur.com
Web site: http://www.sanofipasteur.com/
http://www.sanofipasteur.us/
