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Proper Name
Diphtheria & Tetanus Toxoids & Acellular Pertussis Adsorbed, Inactivated Poliovirus & Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine
Active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b.

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.

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

Advanced Facts