Newron re-files Xadago (safinamide) at FDA as a treatment for Parkinsons disease.

Newron has re-submitted the New Drug Application (NDA) for Xadago (safinamide) to the FDA as a treatment for Parkinsons disease The FDA communicated to Newron in a meeting in July that clinical studies to evaluate the potential abuse liability or dependence/withdrawal effects of Xadago were no longer required. The meeting had been scheduled following the March 29, 2016 Complete Response Letter (CRL) by the FDA. The FDA agreed that the re-submission did not require any new data/studies/analyses for efficacy or safety in patients with Parkinson�s disease. As a class 2 resubmission, the FDA is expected to complete its review of the re-submission within 6 months of acceptance.

Comment: Xadago was EU approved in February 2015.