FDA Says It Needs More Information From Discovery Laboratories (DSCO)
10/19/2005 5:09:08 PM
WARRINGTON, Pa., Aug. 15, 2005 (PRIMEZONE) -- Discovery Laboratories, Inc. (NasdaqNM:DSCO - News), announces that it has received a preliminary communication from the U.S. Food and Drug Administration (FDA) indicating that the Company's previously submitted Response Letter is not considered complete at this time. The FDA notified Discovery that it will provide, later this week, its official written communication regarding select matters for which the FDA may be requesting additional information. The Company previously submitted its Response Letter to the FDA's Approvable Letter for Surfaxin(r) (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants on July 29, 2005.