US FDA backs updated product specifications for Surfaxin
US specialty drugmaker Discovery Laboratories (Nasdaq: DSCO) says that the US Food and Drug Administration has agreed to the company's updated product specifications for Surfaxin (lucinactant) Intratracheal Suspension, which has been approved by the agency for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS (The Pharma Letter March 7, 2012).
The company 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.
Competition in the RDA sector
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