WASHINGTON The Food and Drug Administration is delaying GlaxoSmithKline, the world’s second-largest drugmaker, from selling a new pediatric booster vaccine called Kinrix, according to published reports.
Kinrix is indicated to prevent four childhood diseases, Diphtheria, Tetanus, Whooping cough and Polio. The company received a complete response letter from the FDA, which, according to agency spokesperson Karen Riley, is a request for more information about the vaccine.
The U.S. Centers for Disease Control and Prevention recommends that children get vaccines for each of these diseases between the ages of four and six, and GSK is hoping that this new booster will be able to cover all the risks for children contracting these specific diseases.
GSK’s intention to quickly market this new vaccine is in partial reaction to the company’s drop in revenue from top-selling products and new competition from generic companies. According to published reports, the sale of vaccines will help offset the declines in sales by 20 percent in 2007. It is also expected to be one of the key drivers in the company’s growth for the next couple of years.