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.