Proquad

Proper Name: Measles, Mumps, Rubella and Varicella Virus Vaccine Live

ProQuad (Measles, Mumps, Rubella and Varicella Virus Vaccine Live) is a combined, attenuated, live virus vaccine containing measles, mumps, rubella, and varicella viruses.

Advisory Board:

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.

Indications: Active immunization for the prevention of measles, mumps, rubella, and varicella in individuals 12 months through 12 years of age.

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

Package Insert