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06 November 2013 - FDA awards Orphan Drug Designation for NLX-101

Neurolixis Inc. announced today that its application for Orphan Drug Designation for NLX-101 has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of Rett syndrome (see FDA page). Rett syndrome is a debilitating genetic neurodevelopmental disorder that causes extensive problems in brain function and a wide range of disabilities. NLX-101 (also known as F15599) is targeted to the breathing difficulties and other health problems that are commonly experienced by Rett syndrome patients. Orphan Drug designation provides a seven-year period of U.S. marketing exclusivity as well as other benefits. 

Read the full press announcement:  pdf_symbol.