ENGERIX-B [Hepatitis B Vaccine (Recombinant)] is a sterile suspension of noninfectious HBsAg for intramuscular administration. It contains purified surface antigen of the virus obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus.
09/2011 - GSK submitted a Type C Meeting Request
09/20/2015 - PDUFA Goal Date
12/19/2018 - FDA approval date
The review team and CBER management determined that the discussion of the review of Engerix-B by the Vaccines and Related Biological Products Advisory Committee was not necessary because of CBER’s experience with the currently licensed Engerix-B. Our review of the supplement did not raise concerns or controversial issues which would have benefited from an advisory committee discussion.