Surfaxin receives third "approvable" letter
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Discovery Laboratories' synthetic surfactant receives a third "approvable" letter May 1, despite having reached an agreement on labeling with FDA and successfully completing manufacturing inspection. Discovery submitted Surfaxin (lucinactant) in 2004 for prophylaxis of respiratory distress syndrome in premature infants. The previous approvable letters detailed concerns with product stability and chemistry, manufacturing and controls. The May 1 letter does not cite analytical chemistry methodology, drug product impurity qualification or comparability of the commercial manufacturing process versus that used for the study, Discovery stated, but it does cover CMC issues. According to the firm, FDA requested further clarification of the release and stability biological activity test, tighter acceptance criteria for lipid drug substance impurities and other physical and chemical acceptance criteria, and summary information from certain equipment-related qualification reports. Discovery has scheduled a meeting with FDA to clarify the requests. The firm projects taking 6-8 weeks to complete the response, expected to be a 60-day class 1 resubmission