FDA gives approval to sell children's skin infection drug

The U.S. Food and Drug Administration gave an approval to GlaxoSmithKline PLC said to market a new treatment for a skin infection children usually suffer from.

Glaxo's anti-bacterial treatment Altabax was approved to treat impetigo caused by strains of Staphylococcus aureus or Streptococcus pyogenes, the two most common types of bacteria in this kind of infection.

Widespread use of antibiotics has led to bacteria becoming resistant to some drugs, creating a need for new treatments. Glaxo says Altabax is the first of a new class of prescription antibacterial in nearly two decades.

The company said that Altabax, also known as retapamulin, belongs to a new class of antibiotics, pleuromutilins, that inhibit bacteria from making proteins.

Glaxo sought permission to sell the drug in November 2005 and submitted data from a late-stage trial of 712 patients in the United States. In December, the company said the FDA had requested more information on the drug.

Impetigo is a highly contagious infection of the top layers of the skin and is most common among infants and children ages 2 to 6 years. Children are especially susceptible to infections because their immune systems are still developing.

Glaxo shares were up 2 percent at 1,461 pence (US$29.01; EUR21.54) on the London Stock Exchange.