Measles, Mumps, Rubella and Varicella Virus Vaccine Live
Active immunization for the prevention of measles, mumps, rubella, and varicella in individuals 12 months through 12 years of age.
ProQuad (Measles, Mumps, Rubella and Varicella Virus Vaccine Live) is a combined, attenuated, live virus vaccine containing measles, mumps, rubella, and varicella viruses.
Key Regulatory Milestones
11/01/2013 - Type C meeting briefing package submitted
11/22/2013 - written feedback by CBER
12/02/2013 - Merck agreed with CBER’s recommendations in written feedback
03/16/2017 - PDUFA Goal Date
09/15/2020 - FDA approval date
A Vaccines and Related Biologics Products Advisory Committee (VRBPAC) meeting was not held as there were no issues or concerns that presented during the course of review of the supplement that required consult from the advisory committee.