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FDA approves Discovery Labs respiratory drug

WARRINGTON, Pa. (AP) -- Discovery Laboratories Inc. said Tuesday that the Food and Drug Administration approved its drug Surfaxin, designed to prevent respiratory distress syndrome in premature infants.

Respiratory distress syndrome is a condition in which children are born without enough pulmonary surfactant, a substance produced by the lungs that is essential for breathing. RDS is often treated with mechanical ventilation and animal-derived surfactant replacements. Discovery Labs said around 90,000 infants are treated with those replacement therapies every year.

Surfaxin, or lucinactant, is approved for the prevention of RDS in premature infants who are at high risk for developing the condition. Discovery Labs said it expects the drug to be available in the U.S. in late 2012.

Discovery Laboratories shares rose 17 cents, or 4.8 percent, to close at $3.75. The stock jumped $1.13, or 30.1 percent, to $4.88 in after-hours trading.