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 - 241 KB) - April, 2008


Date: October 7, 2008
Revised Package Insert : To include changes to the package insert to incorporate post-marketing safety information regarding anaphylaxis.
October 7, 2008 Approval Letter

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)

 
Updated: October 15, 2008