Newron Pharmaceuticals S.p.A. announced that it received a Paragraph IV Notice Letter regarding the submission by a generic manufacturer of an Abbreviated New Drug Application to the U.S. Food and Drug Administration (FDA), seeking approval to engage in the commercial manufacture, use or sale of safinamide mesylate drug product in the U.S. before expiration of certain US patents. Newron is reviewing the details of this Notice Letter and will respond as appropriate to protect its intellectual property rights relating to Xadago(R) (safinamide) tablets. Xadago(R) (safinamide) tablets are currently protected by three patents listed in the FDA's Approved Drugs Product List (Orange Book) that expire no earlier than 2026.