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FDA approves GSK’s Infanrix fifth dose indication
North Carolina | Wednesday, July 9, 2003, 08:00 Hrs  [IST]

GlaxoSmithKline announced that its combination vaccine, Infanrix [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed), received approval from the U.S. Food and Drug Administration (FDA) to be administered as a fifth consecutive DTaP vaccine dose for children between the ages of 4 and 6 years for the prevention of diphtheria, tetanus and pertussis (whooping cough).

With the approval of the fifth dose, healthcare professionals can now administer the same brand of DTaP vaccine for the entire five-dose DTaP series, as recommended by the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP) and the American Academy of Family Physicians (AAFP).

"The FDA approval of the fifth-dose indication of Infanrix is an important step toward ensuring that the greatest number of patients receive protection against diphtheria, tetanus and pertussis with a single DTaP brand," said Dr.Richard Judelsohn, medical director, Erie County Department of Health, Buffalo, N.Y. "Children can now receive consistent protection against serious diseases with the proven safety of Infanrix."

The approval of Infanrix for the administration as the fifth DTaP dose comes only months after the FDA approved GlaxoSmithKline's Pediarix [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined], the first and only five-in-one combination vaccine to protect against five diseases, eliminating up to six shots in the process. Now, physicians can confidently administer Pediarix for the first three doses of the DTaP series and finish the series with Infanrix-offering their patients a significant reduction in shots as well as the benefits of using the same brand of DTaP vaccine for all five doses.

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