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)