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Pentacel FDA Approval History

FDA Approved: Yes (First approved June 20, 2008)
Brand name: Pentacel
Generic name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine
Company: Sanofi pasteur
Treatment for: Diphtheria Prophylaxis, Tetanus Prophylaxis, Pertussis Prophylaxis, Poliomyelitis Prophylaxis, Haemophilus influenzae Prophylaxis

Pentacel is a combination vaccine indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b in children 6 weeks through 4 years of age.

Development timeline for Pentacel

Jun 23, 2008Approval U.S. FDA Licenses Sanofi Pasteur's New Pediatric CombinationVaccine, Pentacel
Jan 25, 2007FDA Advisory Committee Recommends Licensure of New Pediatric Combination Vaccine
Sep 26, 2005FDA Accepts for Filing a License Application for New Pediatric Combination Vaccine, Pentacel

Further information

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