Adacel
Adacel is a sterile isotonic suspension of tetanus and diphtheria toxoids and pertussis antigens adsorbed on aluminum phosphate, for intramuscular injection.
Indications: Immunization for prevention of tetanus, diphtheria and pertussis as a single dose in persons 10 through 64 years of age.
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