ZOSTAVAX is a lyophilized preparation of the Oka/Merck strain of live, attenuated varicella-zoster virus (VZV). ZOSTAVAX, when reconstituted as directed, is a sterile suspension for subcutaneous administration.
05/25/2006 - ZOSTAVAX was initially approved
07/12/2007 - supplemental BLA 125123/90 approved
03/24/2011 - Approval for use in persons 50-59 was granted
11/22/2013 - written feedback from CBER in a Type C meeting briefing package submitted on November 1, 2013
10/03/2016 - Merck submitted a BLA supplement
10/04/2016 - Type C meeting
04/22/2018 - PDUFA goal date
02/21/2019 - FDA approval date
A Vaccines and Related Biologics Products Advisory Committee meeting was not held as there were no issues or concerns that presented during the review of the supplement that required consult from the advisory committee.