Proper Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed
Manufacturer: Sanofi Pasteur, Ltd.
- Indicated for active immunization against diphtheria, tetanus and pertussis as a five dose series in infants and children 6 weeks through 6 years of age (prior to 7th birthday).
Final Clinical Review - DAPTACEL(PDF - 414KB) September 16, 2016 Summary Basis of Regulatory Action - DAPTACEL(PDF - 115KB)
- September 16, 2016 Approval Letter - DAPTACEL (PDF - 29KB)
To include immunogenicity and safety data to support the co-administration of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra) with a fifth dose of DAPTACEL in children 4 through 6 years of age.
October 25, 2013 Approval Letter - DAPTACEL[ARCHIVED]
To include the addition of “syncope” under the Adverse Reactions/Post-Market Experience section, etc.
May 29, 2013 Approval Letter - DAPTACEL[ARCHIVED]
To include the addition of an expiration date "(E)" on the detachable portion of the vial label.
July 27, 2012 Approval Letter - DAPTACEL[ARCHIVED]
To include safety information regarding the risk of apnea in premature infants to the Warnings and Precautions section of the package insert.
July 19, 2012 Summary Basis for Regulatory Action-DAPTACEL(PDF - 58KB) July 15, 2011 Approval Letter - DAPTACEL[ARCHIVED]
To include changes to the package insert to update the safety data on use of a fifth dose of DAPTACEL® in children four through six years of age who received four doses of PENTACEL®.
July 12, 2011 Summary Basis for Regulatory Action - DAPTACEL(PDF - 48KB) March 12, 2008 Approval Letter - DAPTACEL[ARCHIVED]
To include a fifth dose booster immunization at 4 to 6 years of age following four previous doses of DAPTACEL.
Committee Chair Approval Memo - DAPTACEL[ARCHIVED] Clinical Review - DAPTACEL(PDF - 178KB) May 14, 2002 Approval Letter - DAPTACEL
Active immunization of infants and toddlers at 2, 4, 6, and 17-20 months of age against diphtheria, tetanus and pertussis.
Clinical Review - DAPTACEL(PDF - 464KB)