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news.The US Food and Drug Administration (FDA) has approved Discovery Laboratories' Surfaxin for the prevention of Respiratory Distress Syndrome (RDS).
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Surfaxin (lucinactant intratracheal suspension) is a synthetic, peptide-containing surfactant, indicated for use in premature infants at high risk for RDS.
Discovery Labs chief executive officer and chairman of the board W. Thomas Amick said the approval of Surfaxin is an important medical advancement for the neonatology community and parents of preterm infants who will soon have an effective alternative to animal-derived surfactants to prevent the development of RDS.
In a large, multinational phase 3 clinical program, the safety and efficacy of Surfaxin for the prevention of RDS in premature infants was demonstrated.
The neonatal medicine is likely to be commercially available in the US in late 2012.
Discovery Laboratories is a specialty biotechnology company which aims to advance a new standard in respiratory critical care.