Proper Name
Varicella Virus Vaccine Live
Indication
Active immunization for the prevention of varicella in individuals 12 months of age and older.
Description
VARIVAX is a preparation of the Oka/Merck strain of live, attenuated varicella virus. The virus was initially obtained from a child with wild-type varicella, then introduced into human embryonic lung cell cultures, adapted to and propagated in embryonic guinea pig cell cultures and finally propagated in human diploid cell cultures (WI-38).
Key Regulatory Milestones
02/20/2017 - PDUFA Goal Date
01/23/2019 - FDA approval date
Advisory Committee
A Vaccines and Related Biologics Products Advisory Committee (VRBPAC) meeting was not held for this supplement, as there were no issues or concerns that presented during the course of review of the supplement that required consult from the advisory committee.
Advanced Facts