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.
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
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.