Discovery's embattled Surfaxin NDA finally accepted by FDA; March 2012 decision
This article was originally published in Scrip
Executive Summary
The US FDA has deemed Discovery Laboratories' application for its humanised surfactant Surfaxin (lucinactant) as a preventive therapy for respiratory distress syndrome (RDS) in premature infants as complete and classified it as a Class 2 submission, setting 6 March 2012 as the Prescription Drug User Fee Act action date.