SURFAXIN GETS ORPHAN DRUG STATUS

Discovery Laboratories has announced that the FDA has granted orphan drug status to Discovery's lead product, Surfaxin, which is a treatment for chronic lung disease in premature infants. Surfaxin, a genetically engineered lung surfactant replacement therapy, received an approvable letter from the FDA earlier this year for its use in preventing respiratory distress syndrome in premature infants.

Surfactants are soap-like substances essential for breathing that lubricate the lining of the lungs and keep them from collapsing.

There are no approved drugs for the treatment of chronic lung disease, also known as bronchopulmonary dysplasia, which is a condition usually associated with a premature infant being treated for respiratory distress syndrome.