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Discovery Labs Reports FDA Approval of SURFAXIN's Updated Specs

Benzinga 13 years ago

NewsFDA

Discovery Laboratories, Inc. (NASDAQ: DSCO) today announced the U.S. FDA has agreed to the Company's updated product specifications for SURFAXIN^® (lucinactant) Intratracheal Suspension which was approved for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS.  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.

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