Discovery Laboratories Inc. announced that the Food and Drug Administration has accepted for review its Complete Response for Surfaxin (lucinactant) for the prevention of respiratory distress syndrome (RDS) in premature infants.

RDS is a life threatening lung disorder that commonly affects premature infants, whose lungs have not yet fully developed. It affects about 10 of every 100 premature infants in the United States, or about 40,000 babies, each year. Nearly all babies born before 28 weeks of pregnancy develop RDS.

The Warrington, Pennsylvania-based company received Approvable Letter for Surfaxin in May 2008, which did not call for any additional clinical trials.

Prior to receiving the Approvable Letter, Discovery Labs stated that it has made progress towards gaining FDA approval of Surfaxin, including agreeing with the FDA on the content of the Surfaxin package insert and successfully concluding a pre-approval inspection of its manufacturing operations.

The FDA has designated the Complete Response as a Class 2 resubmission and has established April 17, 2009 as its target action date to complete the review of the drug.

Surfaxin represents the first peptide-containing synthetic surfactant potentially available for addressing RDS. It has orphan drug designation from the FDA - a status given to therapies being developed for rare condition, affecting 200,000 persons or less in the United States.

Sufaxin is also on clinical trials for bronchopulmonary dysplasia (BPD) and other lung conditions.