Country-specific information on olanzapine

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On 14 January 2004, Lilly reported that the US FDA has approved its 5HT-2/dopamine D2 antagonist olanzapine (Zyprexa) for the maintenance treatment of bipolar disorder.

The approval was based on results from a double-blinded, placebo-controlled study that demonstrated that time to relapse into mania or depression was significantly longer for patients treated with olanzapine than those treated with placebo.

The drug is available in many markets worldwide, including Europe and the USA, for the treatment of schizophrenia and is also approved in the EU and the USA as a monotherapy for the short-term treatment of acute manic episodes associated with bipolar disorder.