FDAnews
www.fdanews.com/articles/67722-fda-approves-sanofi-pasteur-s-bacterial-meningitis-vaccine

FDA APPROVES SANOFI PASTEUR'S BACTERIAL MENINGITIS VACCINE

January 19, 2005

Sanofi Pasteur has received FDA approval for its Menactra vaccine, which is intended to prevent bacterial meningitis.

Menactra is the first vaccine designed to offer protection against four serogroups — the A, C, Y and W-135 strains — of bacterial meningitis, according to Sanofi Pasteur, the vaccines unit of the Sanofi-Aventis Group. The FDA license allows Menactra to be prescribed to adolescents and adults aged 11 to 55, but the company said it intends to file a supplemental license application in early 2005 for use of the vaccine in children younger than 11.

Sanofi Pasteur said it is building a new production facility at its Swiftwater, Pa., site to increase the production of Menactra to meet anticipated demand.