Vanda Pharmaceuticals Inc.
VNDA announced today that the European Medicines Agency
accepted for evaluation Vanda's Marketing Authorization Application
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(R) 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(R). 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.
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