PEDIARIX
PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine] is a noninfectious, sterile vaccine for intramuscular administration.
Indications: • PEDIARIX is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis, infection caused by all known subtypes of hepatitis B virus, and poliomyelitis. • PEDIARIX is approved for use as a 3-dose series in infants born of hepatitis B surface antigen (HBsAg)-negative mothers. • PEDIARIX may be given as early as 6 weeks of age through 6 years of age (prior to the 7th birthday).
Key Regulatory Milestones:
06/29/2007 – GSK submitted the final study report for Study 217744/088 to the Pediarix IND
09/26/2007 – Supplement to the Pediarix BLA (STN 103907/5227), submitted
07/25/2008 – Complete Response letter was issued to GSK Biologics requesting additional datasets and clarification of statistical analyses
06/04/2009 – a complete response to the July 25, 2008, letter was received
11/20/2009 – major amendment was submitted
03/05/2010 – PDUFA goal date
11/06/2019 – FDA approval date