Thursday, October 25, 2012

Lurasidone MAA by Dainippon Sumitomo Pharma and Takeda accepted by EMA

 Dainippon Sumitomo Pharma Co., Ltd. and Takeda Pharmaceutical Company Limited announced that the European Medicines Agency (EMA) has confirmed the acceptance for review of the Marketing Authorization Application (MAA) for an atypical antipsychotic medication lurasidone hydrochloride for the treatment of schizophrenia. The MAA was filed by Takeda Global Research & Development Centre (Europe).

Takeda entered into a license agreement with DSP stipulating the joint development and grant of an
exclusive commercialization right of the product to Takeda in 26 member states of the European Union
(excluding the United Kingdom), and Switzerland, Norway, Turkey and Russia in March 2011.

Lurasidone (brand name LATUDA®) was approved for the treatment of schizophrenia by the United States Food and Drug Administration on 28 October 2010 and by Health Canada on 13 June 2012.

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