Discovery responds to FDA review approvable letter for Surfaxin

WARRINGTON, Pa. Discovery Labs submitted its complete response to a Food and Drug Administration approvable letter it received in May for the drug Surfaxin.

Surfaxin (lucinactant) is designed to treat respiratory distress syndrome in premature babies. The FDA’s guidelines state that the agency will notify Discovery of a potential approval date by Oct. 31.

The approvable letter did not require additional clinical trials, but did require Discovery to satisfy International Conference of Harmonization guidelines related to specifications for lipid-related impurities in two of the ingredients in Surfaxin, as well as an additional preclinical studies for quality control.

Discovery said the FDA could approve the drug within six months, depending on how it classifies the company’s complete response.