Adenovirus Type 4 and Type 7 Vaccine, Live, Oral contains viable, selected strains of human adenovirus Type 4 and human adenovirus Type 7 prepared in human-diploid fibroblast cell cultures (strain WI-38).
09/30/2008 - submitted biologics license application (BLA) 125296
07/2004 - Efficacy and safety data in the BLA first submitted
07/16/2009 - Complete Response letter was sent to the applicant
09/13/2010 - submitted a complete response to the Complete Response letter
03/16/2011 - response reset the review clock to a due date
03/16/2011 - PDUFA Goal Date
10/15/2019 - FDA approval date
The application was not referred to the Vaccines and Related Biological Products Advisory Committee because the review of information submitted in the Biologics License Application (BLA), including the clinical study design and trial results, did not raise concerns or controversial issues which would have benefited from an advisory committee discussion.