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news.Vanda Pharmaceuticals has received the European Medicines Agency's (EMA) acceptance for evaluating its marketing authorization application (MAA) for oral iloperidone tablets.
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Currently, Iloperidone is marketed by Novartis Pharmaceuticals under the name Fanapt, as per an agreement signed between Vanda and Novartis Pharma AG in 12 October 2009.
Under the terms of the agreement, Vanda retained rights to commercialize iloperidone oral and long-acting injectable formulations outside the US and Canada.
Vanda president and CEO Mihael Polymeropoulos said the submission in the European Union is an important milestone towards advancing the iloperidone franchise.
"This continues our efforts to expand the availability of Fanapt to markets outside the US and Canada," Polymeropoulos said.