Product Approval Information
Proper Name: Meningococcal Polysaccharide (Serogroups A, C, Y and W-135) Diphtheria Toxoid Conjugate Vaccine
Tradename: Menactra
Manufacturer: Sanofi Pasteur Inc, License #1725
Package Insert (PDF - 374 KB) - October, 2007
Date: October 18, 2007
Indication: Expanded age indication for subjects 2-10 years of age
October 18, 2007 Approval Letter
FDA Expands Age Range for Use of Bacterial Meningitis Vaccine - 10/18/2007
Consumer Update: Wider Age Range for Bacterial Meningitis Vaccine - 10/29/2007
Date: March 30, 2007
Indication: To include a single dose syringe presentation
March 30, 2007 Approval Letter
Date: January 14, 2005
Indication: Active immunization of adolescents and adults 11-55 years of age for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135
January 14, 2005 Approval Letter
Clinical Review - (Part 1 - PDF 1.5 MB),
(Part 2 - PDF 1.7 MB),
(Part 3 - PDF 1.5 MB)