AstraZeneca reported that the Netherlands Health Authority refused its application for Seroquel XR (quetiapine) in the treatment of recurrent depressive episodes in adults with major depressive disorder (MDD). The drugmaker, which said it referred the application to a committee of the European Medicines Agency for further assessment, also announced that the antipsychotic drug was approved in Canada this month for the treatment of MDD.

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Company spokesman Neil McCrae explained that the refusal in the Netherlands, which was acting as the reference member state for the mutual recognition process, was due to the regulator’s conclusion that there was a “negative benefit risk.” He explained that if the EMEA’s Committee for Medicinal Products for Human Use issues a positive opinion for Seroquel XR for the MDD indication, approval in the EU could be expected in the first quarter of 2010.

Source: FirstWord

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