Proper Name: Hepatitis B Vaccine (Recombinant)
Manufacturer: GlaxoSmithKline Biologicals, License #1617
Indications: ENGERIX-B is a vaccine indicated for immunization against infection caused by all known subtypes of hepatitis B virus.
September 15, 2015 Approval Letter - Engerix-B(PDF - 30KB)
To include safety and immunogenicity data for adults with type 2 diabetes mellitus in the Engerix-B Package Insert Prescribing Information.
September 11, 2015 Summary Basis for Regulatory Action - Engerix - B(PDF - 110KB) November 25, 2013 Approval Letter - Engerix-B
To include language in the package insert addressing the presence of natural rubber latex in the pre-filled syringe tip cap component.
July 16, 2012 Approval Letter - Engerix-B[ARCHIVED]
Updated information regarding instruction on the method of vaccine administration to the Dosage and Administration section of the package insert.
March 12, 2012 Approval Letter- ENGERIX-B[ARCHIVED]
To include changes to the package insert to include "syncope" to the Warnings and Precaution section in Highlights and the Full Prescribing Information
February 27, 2012 Approval Letter - Engerix-B[ARCHIVED]
To include updated information regarding multiple sclerosis in the Warnings and Precautions section of the package insert.
December 23, 2010 Approval Letter - Engerix-B[ARCHIVED]
Revisions to the package insert in order to comply with the Physician Labeling Rule.
Dear Healthcare Provider Letter: Information Re: Engerix-B (Hepatitis B Vaccine (Recombinant)) Tip Caps of the Prefilled Syringes May Contain Natural Rubber Latex Which May Cause Allergic Reactions in Latex Sensitive Individuals[ARCHIVED] August 23, 2010 Approval Letter - Engerix-B[ARCHIVED]
Revised Package Insert and pre-filled syringe carton to include the appropriate warnings regarding latex containing components.
June 2, 2010 Approval Letter - Engerix[ARCHIVED]
Revised the package insert to include new National Drug Code (NDC) numbers for pre-filled syringes that contain no latex and a statement regarding the availability of pre-filled syringes with and without latex containing components.
May 5, 2010 Approval Letter - Engerix-B[ARCHIVED]
Updated: The Prescribing Information to include the addition of new adverse events and a warning regarding apnea in premature infants.
December 23, 2009 Approval Letter - Engerix-B[ARCHIVED]
To update the Package Insert to include the addition of text to visually inspect vials or syringes for cracks prior to administration.
October 15, 2009 Approval Letter - Engerix-B[ARCHIVED]
Introduction of a 10 pack carton of Engerix-B 10 mcg Pre-Filled Syringes for Pediatric/Adolescent use, and accompanying Package Insert.
January 30, 2007 Approval Letter - Engerix-B[ARCHIVED]
March 28, 2000 Approval Letter - Engerix-B[ARCHIVED]
Preservative-free pediatric monodose presentation.
July 7, 1998 Approval Letter - Engerix-B[ARCHIVED]
In individuals (adults) with chronic Hepatitis C infection.
Summary for Basis of Approval - Engerix-B(PDF - 649KB) Clinical Review - Engerix-B(PDF - 296KB) [ARCHIVED]