STN: BL 103552
Proper Name: Varicella Virus Vaccine, Live
Manufacturer: Merck & Co, Inc, License #0002
- For active immunization of persons 12 months of age and older.
- Optional second dose for children 12 months to 12 years of age.
March 28, 2014 Approval Letter - Varivax
To add the term “necrotizing retinitis (in immunocompromised individuals)” to section 6.2 of the US Prescribing Information (USPI).
September 12, 2013 Approval Letter - Varivax[ARCHIVED]
To revise package insert.
December 11, 2012 Approval Letter-Varivax[ARCHIVED]
To include revised labeling in Physician Labeling Rule (PLR) format submitted under section 351 of the Public Health Service Act (42 U.S.C. 262).
February 3, 2012 Approval Letter - Varivax[ARCHIVED]
Revise the Package Insert and the Patient Product Information sheet for the refrigerator-stable and frozen formulations to include “varicella (vaccine strain)”
September 29, 2011 Approval Letter - Varivax[ARCHIVED]
To extend the storage time for the Frozen Formulation from 3 days to 8 days when stored at 2°C to 8°C.
October 13, 2010 Approval Letter - Varivax[ARCHIVED]
Update: Package Insert and Patient Product Information sheets to include changes to the Adverse Reaction and Risk of Vaccine Transmission section
June 3, 2009 Approval Letter - Varivax[ARCHIVED]
To include use of a Patient Package Insert.
October 30, 2008 Approval Letter - Varivax[ARCHIVED]
To remove the phrase “(Oka/Merck)” from the generic name on the product carton and container labeling, and from the package insert.
April 5, 2005 Approval Letter - Varivax[ARCHIVED]
New Indication: Optional second dose for children 12 months to 12 years of age.
Review - Part 1 - Varivax(PDF - 1.7MB) March 17, 1995 Approval Letter - Varivax
Summary for Basis of Approval - Varivax(PDF - 1.5MB) Protocols - Varivax(PDF - 847KB) [ARCHIVED]
FDA Online Label Repository
Search this database for drug labeling and other information. The content has not been altered or verified by the FDA and may not be the labeling on currently distributed products or identical to the labeling that is approved.