Proper Name: Hepatitis B Vaccine (Recombinant)
Manufacturer: GlaxoSmithKline Biologicals
Indications: ENGERIX-B is a vaccine indicated for immunization against infection caused by all known subtypes of hepatitis B virus.
April 28, 2016 Approval Letter – ENGERIX-B(PDF - 29KB)
To change the product labeling in accordance with the guidance for industry issued on December 2, 2014, titled, “Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not made with Natural Rubber Latex.”
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 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 B - 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 - ARCHIVED