Bexsero Purple Book BLA 125546

BLA number: 125546
Proprietary names: Bexsero
Proper names: Meningococcal Group B Vaccine
Applicant: GlaxoSmithKline Biologicals
Center: CBER
First observed release: 2020-08-01
Latest observed release: 2026-06-01
Newest archive release: 2026-06-01
FDA patent list: No patents listed in the captured FDA patent list; source updated 2025-06-11
Coverage: Present in newest release

Latest Known Product Presentations#

Product, Proprietary name, Proper name table
Product	Proprietary name	Proper name	License type	Strength	Dosage form	Route	Presentation	Marketing	Licensure	Approval	Patent list provided
001	Bexsero	Meningococcal Group B Vaccine	351(a)	0.5ML	Injection	Intramuscular	Pre-Filled Syringe	Rx	Licensed	2015-01-23

Published Patent List#

No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.

NDC, Proprietary name, Nonproprietary name table
NDC	Proprietary name	Nonproprietary name	Labeler	Source
58160-976	Bexsero	NEISSERIA MENINGITIDIS SEROGROUP B NHBA FUSION PROTEIN ANTIGEN, NEISSERIA MENINGITIDIS SEROGROUP B FHBP FUSION PROTEIN ANTIGEN and NEISSERIA MENINGITIDIS SEROGROUP B NADA PROTEIN ANTIGEN	GlaxoSmithKline Biologicals SA	current

Official Monthly Change Events#

Release, Event, Product table
Release	Event	Product	Name	License type	Status	Applicant
2021-05-01	U	001	Bexsero	351(a)	Rx	GlaxoSmithKline Biologicals
2020-08-01	R	001	Bexsero	351(a)	Rx	GlaxoSmithKline Biologicals

Observed Product State History#

Release, Product, Name table
Release	Product	Name	License type	Marketing	Licensure	Approval
2020-08-01	001	Bexsero	351(a)	Rx	Licensed	2015-01-23