Pentacel consists of a Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus (DTaP-IPV) component and an ActHIB® component combined through reconstitution for intramuscular injection.
09/21/2010 - Sanofi submitted an Investigational New Drug Application (IND), 14496
08/13/2014 - MCM submitted a Biologics License Application (BLA).
02/14/2018 - submitted a request to IND 14496 for withdrawing that proprietary name of the vaccine
02/16/2018 - submitted a Proprietary Name Review (PNR) request to the same IND for changing the name of the product from to VAXELIS.
06/19/2018 - CBER provisionally accepted VAXELIS as the proprietary name of the vaccine.
06/27/201 - MCM submitted a PNR request to the BLA
11/01/2015 - CBER issued a two-item CR letter
06/29/2018 - MCM submitted a response to the CR letter
12/29/2018 - 6-month review clock with a Resubmission Action Due date initiated
07/30/2012 - PDUFA goal date
12/19/2019 - FDA approval date