The FDA has approved updated product specifications for Surfaxin (lucinactant), allowing Discovery Laboratories to initiate manufacturing for its planned commercial introduction in the fourth quarter of 2013.
Surfaxin Intratracheal Suspension is approved for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS. It is the first synthetic, peptide-containing surfactant approved by the FDA and the only approved alternative to animal-derived surfactants currently used today.
Endogenous pulmonary surfactant lowers surface tension at the air-liquid interface of the alveolar surfaces during respiration and stabilizes the alveoli against collapse at resting transpulmonary pressures.
A deficiency of pulmonary surfactant in premature infants results in RDS. Surfaxin compensates for the deficiency of surfactant and restores surface activity to the lungs of these infants.
For more information call (215) 488-9300 or visit Surfaxin.com.