- For active immunization against disease caused by hepatitis A virus (HAV) for persons 12 months of age and older.
April 25, 2016 Approval Letter – HAVRIX(PDF - 33KB)
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.”
November 25, 2013 Approval Letter - Havrix[ARCHIVED]
To include language in the package insert addressing the presence of natural rubber latex in the pre-filled syringe tip cap component.
June 11, 2013 Approval Letter-HAVRIX[ARCHIVED]
To include a revision of the United States prescription information’s (USPI).
July 16, 2012 Approval Letter - Havrix[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 - HAVRIX[ARCHIVED]
To the package insert to include "syncope" to the Warnings and Precaution section in Highlights and the Full Prescribing Information.
July 21, 2011 Summary Basis for Regulatory Action - Havrix(PDF - 188KB) July 22, 2011 Approval Letter - Havrix[ARCHIVED]
To include immunogenicity and safety data to support concomitant administration of Havrix with M-M-R®II and VARIVAX® among children 12-15 months of age.
Dear Healthcare Provider Letter: Information Re: Havrix (Hepatitis A Vaccine) Tip Caps Of The Prefilled Syringes May Contain Natural Rubber Latex Which May Cause Allergic Reactions In Latex Sensitive Individuals August 23, 2010 Approval Letter - Havrix[ARCHIVED]
Revisd the Package Insert and pre-filled syringe carton to include the appropriate warnings regarding latex containing components.
June 2, 2010 Approval Letter - Havrix[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.
December 14, 2009 Approval Letter - Havrix[ARCHIVED]
To update the package insert to include additional adverse events.
October 1, 2009 Approval Letter[ARCHIVED]
This fulfills your commitment to assess the safety and immunogenicity of concurrent administration of HAVRIX® (720 EL.U/0.5 mL dose) with Infanrix and ActHIB in healthy children 12 to 15 months of age.
September 17, 2009 Approval Letter - Havrix[ARCHIVED]
Changes to the package insert regarding the possibility of cracked vials or syringes.
March 26, 2008 Approval Letter - Havrix[ARCHIVED]
To include coadministration of Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) (Prevnar®) with Hepatitis A Vaccine Inactivated (Havrix®) for children in the second year of life.
February 21, 2006 Approval Letter - Havrix[ARCHIVED]
Package insert labeling changes regarding geriatric use.
October 17, 2005 Approval Letter - Havrix
To support lowering the age indication for Havrix from two years to 12 months of age.
Clinical Review - Havrix(PDF - 772KB) Summary Basis for Regulatory Action - Havrix(PDF - 7.2MB)