Discovery Laboratories (DSCO) Release: Surfaxin Process Validation Batches Achieve Stability Milestone to Enable Filing of Response to FDA Approvable Letter
10/1/2007 9:43:23 AM
WARRINGTON, Pa., Oct. 1, 2007 (PRIME NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO) today announces that its new Surfaxin(r) (lucinactant) process validation batches have demonstrated acceptable stability at six months under Discovery Labs' comprehensive stability testing protocol. This six-month stability data will be included, along with other data and information, in a formal response to the U.S. Food and Drug Administrations' (FDA) April 2006 Approvable Letter for Surfaxin for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. Discovery Labs remains on track to file its response to the FDA Approvable Letter in the October 2007 timeframe, followed by an anticipated six-month review cycle by the FDA for potential approval of the Surfaxin New Drug Application (NDA).