Newron resubmits New Drug Application for Xadago

Newron Pharmaceuticals, in association with its partners Zambon and US WorldMeds, has resubmitted the U.S. New Drug Application in September seeking a complete Class 2 response by the U.S. Food and Drug Administration (FDA) for Xadago, also known by its generic name, safinamide.
The FDA’s Complete Response Letter (CRL) was received on March 28. The FDA has decided that the user fee goal date (PDUFA date) will be March 21, 2017.
The drug in question is Xadago, also known by its generic name, safinamide, which is a chemical medication that can select and reverse the inhibition of MAO-B and block sodium channels that are voltage dependent. This affects the released of abnormal glutamate.
Xadago has been proved effective in controlling short-term motor symptoms and complications by clinical trials.
Newron Pharmaceuticals centers itself around biopharmaceuticals and the development of novel therapies for the treatment of patients with central nervous system diseases and pain,