Discovery says Surfaxin is unlikely to get US FDA approval
This article was originally published in Scrip
Executive Summary
Discovery Laboratories said that its troubled lung drug Surfaxin (lucinactant) is unlikely to achieve US FDA approval for the prevention of respiratory distress syndrome (RDS) in premature infants. The problem stems from the standards that the agency will use to assess whether the Surfaxin product that was used in Phase III trials is the same as the Surfaxin product that would be marketed and distributed. The company's shares fell nearly 50% on Nasdaq, to 54.5 cents, on July 2nd.