Discovery Labs’ Response to Surfaxin Approvable Letter Deemed Complete

The FDA has accepted Discovery Laboratories’ Nov. 1 submission as a complete response to the April 2006 approvable letter for Surfaxin, a treatment for the prevention of respiratory distress syndrome in premature infants.

The FDA has established May 1, 2008, as its target date to complete its review of the Surfaxin (lucinactant) new drug application.

The letter did not require any additional clinical trials and focused on the chemistry, manufacturing and controls section of the application involving drug product specifications and stability, analytical methods and related controls, Discovery said.