TRUMENBA
STN: BL 125549
Proper Name: Meningococcal Group B Vaccine
Trade Name: TRUMENBA
Manufacture: Wyeth Pharmaceuticals, Inc.
Indication:
- Indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. Trumenba is approved for use in individuals 10 through 25 years of age.
Product Information
Supporting Documents
March 14, 2018 Approval Letter - Trumenba (PDF - 96KB)
To revise the package insert labeling to include additional information.January 10, 2018 Approval Letter - Trumenba (PDF - 33KB)
To include information regarding an additional (single dose) syringe presentation.September 26, 2017 Approval Letter - Trumenba (PDF - 26KB)
To revise the package insert.March 13, 2017 Summary Basis for Regulatory Action - Trumenba (PDF - 113KB)March 13, 2017 Approval Letter - Trumenba (PDF - 39KB)
To include data from two confirmatory clinical studies to verify and describe the clinical benefit of the three-dose schedule (a dose administered at 0, 1-2, and 6 months) of Trumenba.April 14, 2016 Approval Letter - TRUMENBA (PDF - 61KB)
To include a two-dose schedule (a dose administered at 0 and 6 months) according to the regulations for accelerated approval and a modification of the three-dose schedule from administration at 0, 2, and 6 months to administration at 0, 1-2, and 6 months.Statistical Review of STN 125549/17 - TRUMENBA (PDF - 479KB)Addendum to Statistical Review of STN 125549/17 (PDF - 57KB)Clinical Review of 125549/17 - TRUMENBA (PDF - 474KB)April 14, 2016 Summary Basis for Regulatory Action - TRUMENBA (PDF - 116KB)December 9, 2014 Approval Letter - TRUMENBA October 29, 2014 Approval Letter - TRUMENBA October 29, 2014 Summay Basis for Regulatory Action - TRUMENBA (PDF - 176KB)Clinical Review - TRUMENBA (PDF - 856KB)Statistical Review - TRUMENBA (PDF - 1MB)Approval History, Letters, Reviews, and Related Documents - TRUMENBA (ZIP - 5.9MB)