Discovery Labs Says FDA Approves Surfaxin Updated Product Specifications

(RTTNews) - Discovery Laboratories Inc. (DSCO) announced Friday that the U.S. Food and Drug Administration or FDA has agreed to the company's updated product specifications for Surfaxin or lucinactant Intratracheal Suspension which was approved for the prevention of respiratory distress syndrome or RDS in premature infants at high risk for RDS.

The company stated that it has initiated manufacturing of Surfaxin for its planned commercial introduction in the fourth quarter of 2013. SURFAXIN is the first FDA-approved synthetic, peptide-containing surfactant available for the prevention of RDS in premature infants and the only approved alternative to animal-derived surfactants currently used today.

The company noted that Surfaxin is intended for intratracheal use only. The administration of exogenous surfactants, including Surfaxin, can rapidly affect oxygenation and lung compliance. Infants receiving Surfaxin should receive frequent clinical assessments so that oxygen and ventilatory support can be modified to respond to changes in respiratory status.

Surfaxin is not indicated for use in acute respiratory distress syndrome or ARDS, the company said.