PENTACEL

Proper Name: Diphtheria & Tetanus Toxoids & Acellular Pertussis Adsorbed, Inactivated Poliovirus & Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine

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.

Indications: Active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b.

Key Regulatory Milestones:

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

Package Insert