BioCentury
ARTICLE | Clinical News

Xadago safinamide regulatory update

October 31, 2016 7:00 AM UTC

Newron said FDA accepted a resubmitted NDA for Xadago safinamide from Newron as an add-on therapy for early and mid- to late-stage Parkinson’s disease (PD). The PDUFA date is March 21, 2017. In March, FDA issued a complete response letter for Xadago requesting clinical evaluation of Xadago’s potential effects on behaviors relating to abuse liability and its dependence and withdrawal effects (see BioCentury, April 4)...