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Proper Name
Hepatitis B Vaccine (Recombinant)
ENGERIX-B is a vaccine indicated for immunization against infection caused by all known subtypes of hepatitis B virus.

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.

Key Regulatory Milestones

09/2011 - GSK submitted a Type C Meeting Request

09/20/2015 - PDUFA Goal Date

12/19/2018 - FDA approval date

Advisory Committee

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.

Advanced Facts