Discovery Labs could see Surfaxin approval by year-end
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Discovery Labs says the response to a May 2008 approvable letter for its neonatal respiratory distress syndrome therapy Surfaxin could be designated as a Class 1 resubmission, resulting in a 60-day review period and a mid-December PDUFA target date, the firm says Oct. 17. In September, Discovery announced technical success at addressing the outstanding requirements identified in the third approvable letter for Surfaxin (lucinactant), including completing pre-clinical studies in a biological activity test and satisfying International Conference on Harmonization guidelines for lipid-related impurities in active pharmaceutical ingredients (1Pharmaceutical Approvals Monthly August 2008, In Brief). Labeling discussions and a manufacturing inspection have been successfully completed