Discovery Laboratories, Inc. has received an Approvable Letter from the US Food and Drug Administration (FDA) for Surfaxin (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants.

The notification sets forth the remaining conditions that must be satisfied to gain US marketing approval for Surfaxin. The approvable letter was received in the evening of May 1, 2008, the PDUFA date that had been established for Surfaxin. Prior to receiving the approvable letter, Discovery Labs had finalized Surfaxin labeling discussions with the FDA. In addition, the FDA had completed its pre-approval inspection of Discovery Labs' manufacturing facility in Totowa, New Jersey and recently issued an Establishment Inspection Report (EIR) reflecting a successful inspection.

Discovery Labs is assessing the approvable letter and will contact the FDA within the next few days to discuss required actions and timing to gain Surfaxin approval. Discovery Labs expects to be in a position early next week to provide guidance regarding its plans and timeline considerations to address the approvable letter.

Discovery Laboratories, Inc. is a biotechnology company developing Surfactant Replacement Therapies (SRT) for respiratory diseases.