FDA approves updated Surfaxin (Discovery Labs) for RDS
The FDA has agreed to Discovery Lab's updated product specifications for Surfaxin (lucinactant) Intratracheal Suspension which was approved in 2012 for the prevention of Respiratory Distress Dyndrome (RDS) in premature infants at high risk for RDS. The company plans to launch the drug in 2013 Q4.
Surfaxin was approved by the FDA last year but it requested additional information on how the company documents the drug's product specifications and a new analytical chemistry method. Surfaxin is the first synthetic, peptide-containing surfactant to receive FDA approval and the sole alternative to animal-derived surfactants.
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