FDA issues approvable letter for Surfaxin

WARRINGTON, Pa. The Food and Drug Administration has requested more information from Discovery Labs on its premature infant respiratory distress syndrome distress Surfaxin, delaying the drug’s approval, according to the Associated Press.

The company had expected to receive a decision on approval Thursday. The regulatory agency recently issued an approvable letter outlining additional information requests, details of which the company opted not to disclose in its statement.

Discovery Labs said it will contact the agency in the next few days to discuss next steps.