Discovery Laboratories' Launch of Surfaxin Delayed by Form 483

Discovery Laboratories has suffered a setback in its development of respiratory drug Surfaxin when the contract manufacturer hired to produce the product was issued a Form 483 by the FDA.

Discovery recently revealed that contractor Laureate Pharma was cited by the FDA in January for inspection observations related to current good manufacturing practices, including basic quality controls, process assurances and documentation requirements. The FDA is currently processing Discovery's new drug application for Surfaxin (lucinactant), which is intended to treat respiratory distress syndrome in premature infants.

Although Discovery described the Form 483 observations as "highly correctable," the company said it doesn't anticipate the corrective actions being completed until the summer. Discovery had previously forecasted a second-quarter 2005 launch for Surfaxin, but that target has now been pushed to the fourth quarter, the company said.