Surfaxin is re-filed at FDA for Respiratory Distress Syndrome

The FDA has accepted the re-application for the humanised surfactant Surfaxin (lucinactant) from Discovery Laboratories as a preventive therapy for respiratory distress syndrome (RDS) in premature infants as complete and has classified it as a Class 2 submission, setting 6 March 2012 as the Prescription Drug User Fee Act action date. Respiratory Distress Syndrome is a condition in which premature infants are born with an insufficient amount of their own natural pulmonary surfactant, a substance produced naturally in the lungs and essential for breathing. The condition, which affects about 90,000 premature infants annually in the US, often requires that infants receive surfactant replacement therapy along with mechanical ventilation to survive.