WARRINGTON, Pa., Nov. 1, 2007 (PRIME NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO) announced that it has submitted its formal response to the U.S. Food and Drug Administration’s (FDA) April 2006 Approvable Letter for Surfaxin(r) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. The FDA’s guidelines provide that within 14 days of receipt of the formal submission, if the FDA has accepted the submission as a complete response, it should provide a review classification that determines the targeted review timeframe. Discovery Labs anticipates that the FDA will designate the formal response as a Class 2 submission, thereby allowing for a six-month review period with a target PDUFA date in the second quarter of 2008.
