Proper Name: Zoster Vaccine, Live
Manufacturer: Merck & Co., Inc
- For prevention of herpes zoster (shingles) in individuals 50 years of age and older.
March 15, 2017 Summary Basis for Regulatory Action - ZOSTAVAX(PDF - 159KB) March 15, 2017 Approval Letter - Zostavax(PDF - 43KB)
To include method in the production of Varicella Zoster Virus for varicella-zoster virus (Oka/Merck strain) drug substance.
February 17, 2016 Approval Letter - ZOSTAVAX(PDF - 28KB)
STN 125123/1798, To include a change to the ZOSTAVAX US prescribing information to add “Eye Disorders: necrotizing retinitis (patients on immunosuppressive therapy)” to Section 6.3 (Postmarketing Experience).
August 28, 2014 Approval Letter - ZOSTAVAX
To include “infections and infestations: Herpes zoster (vaccine strain)” and to update the Patient Package Insert to include “Shingles” in the “What are the possible side effects of ZOSTAVAX?” section.
March 24, 2011 Approval Letter - Zostavax
STN 125123/734, To include safety and efficacy data to support a label change for the use of ZOSTAVAX in individuals 50 to 59 years of age.
September 12, 2013 Approval Letter - ZOSTAVAX
To revise information in the package inserts.
December 20, 2011 Approval Letter - Zostavax - ARCHIVED
To add the term “Gastrointestinal disorders: nausea” to Section 6.3 (Postmarketing Experience) of the Package Insert and the term “nausea” to the Patient Product Information circular, has been date stamped and issued.
July 13, 2011 Approval Letter - Zostavax - ARCHIVED
To include changes to the package insert to amend Section 6.2 to include the term "varicella" referring to the 2 rashes previously indentified as varcella-like, has been date stamped and issued.
March 23, 2011 Summary Basis for Regulatory Action (SBRA) - Zostavax(PDF - 35KB) March 30, 2010 Approval Letter - Zostavax - ARCHIVED
STN 125123/654, To include an update in the package insert on instructions for reconstitution and minor editorial correction.
December 18, 2009 Approval Letter - Zostavax - ARCHIVED
STN 125123/430, To approve revised Package Insert to include the statement that Zostavax and Pneumovax 23 should not be given concurrently.
Summary Basis for Regulatory Action - Zostavax(PDF - 94KB)
December 18, 2009
July 28, 2009 Approval Letter - Zostavax - ARCHIVED
STN 125123/424, To include changes to the package insert (adverse reactions and post-marketing experience sections) and patient package circular regarding “transient injection-site lymphadenopathy.”
November 18, 2008 Approval Letter - Zostavax - ARCHIVED
STN 125123/329, To include changes to the package inserts for the frozen and refrigerated formulations.
June 18, 2008 Approval Letter - Zostavax (Frozen) - ARCHIVED
STN 125123/298, To include changes to the package insert and patient product information for the frozen formulation.
June 18, 2008 Approval Letter - Zostavax (Refrigerator) - ARCHIVED
STN 125123/298, To include changes to the package insert and patient product information for the refrigerator stable formulation.
July 6, 2007 Approval Letter - Zostavax - ARCHIVED
STN 125123/90, To include a statement in the package insert regarding concomitant administration of ZOSTAVAX with inactivated influenza vaccine.
May 25, 2006 Approval Letter - Zostavax
STN 125123/0, Approval of biologics license application (BLA) for Zoster Vaccine, Live, (Oka/Merck).
FDA Licenses New Vaccine to Reduce Older Americans' Risk of Shingles - ARCHIVED Zostavax (Herpes Zoster Vaccine) Questions and Answers FDA Online Label Repository
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