HIBERIX

Proper Name: Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)

HIBERIX [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)] is a solution for intramuscular injection, supplied as a sterile, lyophilized powder which is reconstituted at the time of use with the accompanying saline diluent.

Advisory Board:

The application was not referred to the Vaccines and Related Biological Products Advisory Committee because the review of information submitted in this supplement did not raise concerns or controversial issues which would have benefited from an advisory committee discussion.

Indications: For active immunization for the prevention of invasive disease caused by Haemophilus influenzae type b. HIBERIX is approved for use in children 6 weeks through 4 years of age (prior to fifth birthday).

Key Regulatory Milestones:

08/19/2009 – Hiberix was licensed in the US

03/16/2015 – GSK submitted the first efficacy supplement (STN 125347/231, Primary series/PREA)

01/14/2016 – first efficacy supplement (STN 125347/231, Primary series/PREA) approved.

04/30/2018 – PDUFA Goal Date

04/30/2018 – FDA approval date

Package Insert