AUDENZ, a sterile injectable emulsion for intramuscular use, is an inactivated, monovalent, subunit influenza vaccine prepared from virus propagated in Madin Darby Canine Kidney (MDCK) cells, a continuous cell line.
12/2015 - Fast Track designation was granted
05/07/2014 - Type C meeting between the Center for Biologics Evaluation and Research (CBER) and Novartis Vaccines
06/21/2018 - pre-BLA meeting with Seqirus to discuss the manufacturing, pre-clinical and clinical information Seqirus indicated that the plans had changed since the
02/01/2019 - final submission of the rolling BLA for Audenz, (STN 125692).
01/31/2020 - FDA approval date
02/01/2020 - PDUFA Goal Date
An Advisory Committee meeting was not held for Audenz since relevant issues regarding licensure of pandemic vaccines were discussed previously at Vaccines and Related Biological Products Advisory Committee (VRBPAC) meetings held on February 29, 2012, and November 14, 2012; and because our review of information submitted in the BLA did not raise concerns or controversial issues which would have benefited from an advisory committee discussion.