Vaccines, Blood & Biologics
Proper Name: Meningococcal Polysaccharide (Serogroups A, C, Y and W-135) Diphtheria Toxoid Conjugate Vaccine
Manufacturer: Sanofi Pasteur Inc, License #1725
Active immunization of individuals 9 months through 55 years of age for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135
October 25, 2013 Approval Letter - Menactra
To revise the 2D barcode detachable vial label to remove the nonproprietary name and add an NDC, the carton label to include the new Sanofi Pasteur logo.
December 1, 2011 Approval Letter - Menactra
To update the package insert with results from a retrospective study to assess the risk of Guillain-Barre Syndrome (GBS) following administration of Menactra.
Summary Basis For Regulatory Action, December 1, 2011 - Menactra(PDF - 57KB) April 22, 2011 Approval Letter - Menactra
To include safety and immunogenicity data to support use in children 9 through 23 months of age to prevent invasive meningococcal disease caused by N. meningitidis serogroups A, C, Y, and W-135.
Summary Basis for Regulatory Action, April 14, 2011 - Menactra(PDF - 140KB) December 16, 2010 Approval Letter - Menactra
Includes revisions to labeling to address latex information regarding the tip caps of the syringes.
August 3, 2009 Approval Letter - Menactra
Revise Package Insert: To include changes to the package insert regarding formaldehyde levels.
October 7, 2008 Approval Letter-Menactra
Revised Package Insert : To include changes to the package insert to incorporate post-marketing safety information regarding anaphylaxis.
October 18, 2007 Approval Letter
Indication: Expanded age indication for subjects 2-10 years of age.
March 30, 2007 Approval Letter - Menactra
Indication: To include a single dose syringe presentation.
January 14, 2005 Approval Letter
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.
Menactra Clinical Review- (Part 3)(PDF - 1.5MB)
Lot Consistency in Adults 18-55 years old Clinical Study - MTA-14
Clinical Review of New Biologics License Application - Menactra, January 14, 2005(PDF - 1.8MB) Comparative Safety and Immunogenicity Study in Adults 18-55 year Old Clinical Study - Menactra(PDF - 1.9MB)
FDA Online Label Repository
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FDA Expands Age Range for Use of Bacterial Meningitis Vaccine[ARCHIVED]
Press Release: 10/18/2007