On Jun. 23, 2008, Sanofi Pasteur announced the U.S. Food and Drug Administration had licensed Pentacel, Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine.

Pentacel vaccine was indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis, and invasive disease due to Haemophilus influenzae type b (Hib). Pentacel vaccine was approved for use in infants and children 6 weeks through 4 years of age (prior to fifth birthday).