July 9, 2003

GSK GAINS APPROVAL FOR INFANRIX FIFTH DOSE INDICATION

GlaxoSmithKline Plc received Food and Drug Administration approval for its Infanrix vaccine to be administered as a fifth consecutive diphtheria, tetanus toxoids and acellular pertussis (DTaP) adsorbed vaccine dose for young children.

According to GSK, the approval ensures protection against diphtheria, tetanus and whooping cough for children between the ages of 4 and 6 years.

The pharma name Infanrix had already been approved for the three-dose primary series, but the new approval allows for health care professionals to administer the same source of vaccine for the entire five-dose series, as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices and other organizations.

"The approval of the fifth dose of Infanrix provides a substantial benefit for health care professionals, who will likely find a timesaving advantage through efficient ordering and inventory management," said Dr. Barbara Howe, vice president of clinical research and development and medical affairs at GSK's North American vaccines unit.