STN: BL 103907
Proper Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined
Manufacturer: GlaxoSmithKline Biologicals, License #1617
- 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 three-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).
April 25, 2016 Approval Letter - Pediarix(PDF - 28KB)
To change the product labeling in accordance with the guidance for industry issued on December 2, 2014, titled, “Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex.
November 27, 2013 Approval Letter-Pediarix
To change the product labeling in accordance with the guidance issued on March 11, 2013.
March 8, 2013 Approval Letter - PEDIARIX[ARCHIVED]
To include changes to the package insert reflect the discontinuation of the vial presentations.
July 16, 2012 Approval Letter - Pediarix[ARCHIVED]
Updated information regarding instruction on the method of vaccine administration in the Dosage and Administration section of the package insert.
March 12, 2012 Approval Letter - Pediarix[ARCHIVED]
To include changes to the package insert to include "syncope" to the Warnings and Precaution section in Highlights and the Full Prescribing Information.
January 25, 2011 Approval Letter - Pediarix[ARCHIVED]
Revise labeling to address latex hypersensitivity in the Warnings and Precautions section of the package insert.
March 5, 2010 Approval Letter - Pediarix[ARCHIVED]
Revised package insert to include the results from a postmarketing safety surveillance study that evaluated the risk of all seizures (with or without fever).
February 12, 2010 Approval Letter - Pediarix[ARCHIVED]
Revise the Package Insert to add a warning regarding apnea in premature infants and to update the subsection on postmarketing adverse events.
December 13, 2002 Approval Letter - Pediarix
Active immunization against diphtheria, tetanus, pertussis (whooping cough), all known subtypes of hepatitis B virus, and poliomyelitis caused by poliovirus Types 1, 2, and 3.
Clinical Review - November 25, 2002 - Pediarix[ARCHIVED] Clinical Review - November 12, 2001 - Pediarix(PDF - 943KB) Summary Basis for Regulatory Action - Pediarix(PDF - 76KB)