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FDA approves first synthetic surfactant to help premature babies breathe

A drug for preterm infants born with respiratory distress syndrome has been approved by U.S. regulators. The neonatology drug developed by specialty biotechnology company Discovery Labs (NASDAQ:DSCO) is designed to treat the respiratory condition in which preterm infants are born without enough pulmonary surfactant, a substance made by the lungs needed for breathing, according to […]

A drug for preterm infants born with respiratory distress syndrome has been approved by U.S. regulators.

The neonatology drug developed by specialty biotechnology company Discovery Labs (NASDAQ:DSCO) is designed to treat the respiratory condition in which preterm infants are born without enough pulmonary surfactant, a substance made by the lungs needed for breathing, according to a company statement. It is expected to be commercially available later this year.

The respiratory syndrome affects about 90,000 premature infants annually. The current treatment available uses pulmonary surfactant derived from animals. Surfaxin is the first synthetic, peptide-containing surfactant.

The new drug application for Surfaxin was initially submitted by the Warrington, Pennsylvania-based company in 2004. One tweet about the drugmaker drolly observed, “[Discovery Labs] is a great lesson for Mitt Romney. It may take him five tries, but one day he will be president. ;-)”