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Proper Name
Tetanus Toxoid, Reduced Diphtheria Toxoid & Acellular Pertussis Vaccine, Adsorbed
Immunization for prevention of tetanus, diphtheria and pertussis as a single dose in persons 10 through 64 years of age.

Adacel is a sterile isotonic suspension of tetanus and diphtheria toxoids and pertussis antigens adsorbed on aluminum phosphate, for intramuscular injection.

Key Regulatory Milestones

2005 - Adacel was initially approved in the US

06/28/2017 -  submitted a Type C Meeting request under IND 9226 

09/19/2017 - The Type C meeting (CRMTS #10830) was held with the applicant.

12/12/2017 - efficacy supplement for Adacel was submitted under STN 125111/679

01/11/2019 - PDUFA Goal Date

12/28/2020 - FDA approval date

Advanced Facts