SAN DIEGO--(BUSINESS WIRE)--April 4, 2006--AVANIR Pharmaceuticals (AMEX:AVN.R - News) announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing and review its New Drug Application (NDA) for Neurodex(TM) for the treatment of involuntary emotional expression disorder (IEED), also known as pseudobulbar affect or emotional lability. In addition, the Neurodex NDA will receive priority review by the FDA. The FDA grants priority review status to products that, if approved, would address an unmet medical need or are considered to be potentially significant therapeutic advancements over existing approved therapies in the treatment, diagnosis or prevention of a disease. AVANIR completed the submission of its NDA to the FDA on January 27, 2006, and expects the FDA will take action on the NDA by July 30, 2006 (the “PDUFA date”).
