Newron Pharmaceuticals SpA., of Milan, Italy, and its partners, Milan-based Zambon SpA and U.S. Worldmeds LLC, of Louisville, Ky., reported that the FDA considers the September 2016 resubmission of their new drug application for the Parkinson's disease candidate Xadago (safinamide) by Newron to be a complete, class 2 response to the agency's March 28 complete response letter and has set a PDUFA date of March 21, 2017.