Vaccines, Blood & Biologics
Resources for You
- For prevention of herpes zoster (shingles) in individuals 50 years of age and older.
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
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
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 30, 2010 Approval Letter - Zostavax
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
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
November 16, 2009 Approval Letter - Zostavax
STN 125123/461, To include changes to the package insert (adverse reactions and post-marketing experience section) and patient package insert (injection-site rash, injection-site urticaria, arthralgia and myalgia).
July 28, 2009 Approval Letter - Zostavax
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
STN 125123/329, To include changes to the package inserts for the frozen and refrigerated formulations.
June 18, 2008 Approval Letter - Zostavax (Frozen)
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)
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
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]
Press Release: May 26, 2006
Zostavax (Herpes Zoster Vaccine) Questions and Answers 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.
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