STN: BL 125549
Proper Name: Meningococcal Group B Vaccine
Trade Name: TRUMENBA
Manufacture: Wyeth Pharmaceuticals, Inc.
- 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.
- March 14, 2018 Approval Letter - Trumenba
To revise the package insert labeling to include additional information.
- January 10, 2018 Approval Letter - Trumenba
To include information regarding an additional (single dose) syringe presentation.
- September 26, 2017 Approval Letter - Trumenba
To revise the package insert.
- March 13, 2017 Summary Basis for Regulatory Action - Trumenba
- March 13, 2017 Approval Letter - Trumenba
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 Letters - TRUMENBA
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
- Addendum to Statistical Review of STN 125549/17
- Clinical Review of 125549/17 - TRUMENBA
- April 14, 2016 Summary Basis for Regulatory Action - TRUMENBA
- December 9, 2014 Approval Letter - TRUMENBA
- October 29, 2014 Approval Letter - TRUMENBA
- October 29, 2014 Summay Basis for Regulatory Action - TRUMENBA
- Clinical Review - TRUMENBA
- Statistical Review - TRUMENBA
- Approval History, Letters, Reviews, and Related Documents - TRUMENBA