Licensed vaccine
BEXSERO
FDA-licensed vaccine
Key facts
| Trade name | BEXSERO |
|---|---|
| Proper name | Meningococcal Group B Vaccine |
| FDA product areas | Biologics |
| Recent FDA documents | August 19, 2024 Approval Letter - BEXSERO, April 26, 2023 Approval Letter - BEXSERO, January 6, 2022 Approval Letter - BEXSERO, October 24, 2019 Approval Letter - BEXSERO, May 31, 2018 Approval Letter - BEXSERO, October 12, 2017 Approval Letter - BEXSERO, Approval History, Letters, Reviews, and Related Documents - BEXSERO, Statistical Review - BEXSERO, Package Insert - BEXSERO, Clinical Review, January 23, 2015 - BEXSERO, Supporting Documents older than three years - BEXSERO |
| FDA page updated | Aug 20, 2024 |
| FDA product page | fda.gov |
At a glance
- 1–9 FDA approval letters
- 10–99 Supporting documents
- 1–9 Product information documents
- Yes Document full text searchable in Orca1
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-licensed vaccines
The FDA's CBER licenses vaccines for use in the United States. Each product page links the approval letters, package inserts and supporting documents for that vaccine.
Source: U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Vaccines Licensed for Use in the United States · Source date: