Discovery Labs targets filing Surfaxin response with FDA in third quarter
This article was originally published in Scrip
Executive Summary
Discovery Laboratories said it could file a "complete response" with the US FDA early in the third quarter for Surfaxin (lucinactant), its investigational lung surfactant for which an NDA has been pending for respiratory distress syndrome (RDS) in premature infants. The goal of the response is to overcome the remaining primary concerns regarding FDA approval of the product, which involve validation and the biological activity test.