Discovery Labs Submits Response to Second FDA Approvable Letter
Discovery Labs is continuing to pursue approval for its respiratory distress syndrome treatment Surfaxin during the first half of 2008 and has submitted its response to a second FDA approvable letter. The agency action date is May 1, 2008.
Surfaxin (lucinactant) is a synthetic version of natural human lung surfactant and is intended to treat respiratory distress syndrome, a condition occurring in premature infants.
The FDA issued the second approvable letter for the drug last year. It requested additional information regarding the tightening of active pharmaceutical ingredient and drug product specifications. Shortly after receipt of the letter, the company said Surfaxin process validation batches failed stability tests. In its response to the letter, Discovery Labs included data on three new process validation batches that show the drug is stable at six months.
If approved, Surfaxin would compete against Abbott Laboratories’ Survanta (beractant), Forest Pharmaceuticals’ Infasurf (calfactant) and Mylan subsidiary Dey’s Curosurf (poractant alfa).