ROCKVILLE, Md., July 26, 2011 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) announced today that the European Medicines Agency (EMA) accepted for evaluation Vanda's Marketing Authorization Application (MAA) for oral iloperidone tablets. Iloperidone is an atypical antipsychotic for the treatment of schizophrenia in adults.
"The submission in the European Union is an important milestone towards advancing the iloperidone franchise," said Mihael H. Polymeropoulos, M.D., Vanda's President and CEO. "This continues our efforts to expand the availability of Fanapt® to markets outside the U.S. and Canada."
Iloperidone is currently marketed in the U.S. by Novartis Pharmaceuticals Corporation, an affiliate of Vanda's sublicensor Novartis Pharma AG, under the name Fanapt®. Under a 2009 agreement, Novartis has exclusive rights relating to the development and commercialization of iloperidone in the U.S. and Canada. Under the terms of such agreement, Vanda retained rights to commercialize iloperidone oral and long-acting injectable formulations outside the U.S. and Canada.
Schizophrenia is a chronic, severe and disabling mental disorder, characterized by profound disruptions in thinking, affecting language, perception, and the sense of self. It often includes psychotic experiences, such as hearing voices or delusions. Schizophrenia typically begins in late adolescence or early adulthood and affects approximately 5 million Europeans or 1.0% of the E.U. population.
Fanapt® belongs to a class of medications for schizophrenia known as atypical antipsychotics. Fanapt® has been approved by the U.S. Food and Drug Administration for the treatment of schizophrenia in adults. For full U.S. prescribing information, please visit
|SOURCE Vanda Pharmaceuticals Inc.|
Copyright©2010 PR Newswire.
All rights reserved