Product Information

• Package Insert - Menactra (PDF - 1MB)

Supporting Documents

• 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)

Related Information

• FDA Online Label Repository
  Search this database for drug labeling and other information. The content has not been altered or verified by the FDA and may not be the labeling on currently distributed products or identical to the labeling that is approved.
• FDA Expands Age Range for Use of Bacterial Meningitis Vaccine
  Press Release: 10/18/2007

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