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).
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
To include changes to the package insert reflect the discontinuation of the vial presentations.
July 16, 2012 Approval Letter - Pediarix
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
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
Revise labeling to address latex hypersensitivity in the Warnings and Precautions section of the package insert.
March 5, 2010 Approval Letter - Pediarix
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
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 Clinical Review - November 12, 2001 - Pediarix(PDF - 943KB) Summary Basis for Regulatory Action - Pediarix(PDF - 76KB)