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FDA Issues a Complete Response Letter for Lilly's Olanzapine LAI for Treatment of Schizophrenia in Adults
Date:1/7/2009

jected short-acting formulations, long-acting formulations of antipsychotics allow for stable concentrations of the active drug to remain at a therapeutic range for an extended period of time.(3)

About Schizophrenia

Schizophrenia is a severe and debilitating illness with such symptoms as delusions (false beliefs that cannot be corrected by reason), hallucinations (usually in the form of non-existent voices or visions), disorganized speech and severe disorganized or catatonic behavior. These signs and symptoms are associated with marked social or occupational dysfunction. Features of schizophrenia consist of characteristic signs and symptoms that have been present for a significant portion of time during a one-month period, with some signs of the disorder persisting for at least six months.(4) In addition to these symptoms, patients with schizophrenia are at greater risk for medical comorbidities than the general population.

Safety information for Zyprexa

Zyprexa oral is indicated in the United States for the short- and long- term treatment of schizophrenia, acute mixed and manic episodes of bipolar I disorder, and maintenance treatment of bipolar disorder.

    Olanzapine is not approved for the treatment of patients with dementia-
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    related psychosis. Elderly patients with dementia-related psychosis
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    treated with antipsychotic drugs are at an increased risk of death.
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In addition, compared to elderly patients with dementia-related psychosis taking a placebo, there was a significantly higher incidence of cerebrovascular adverse events in elderly patients with dementia-related psychosis treated with olanzapine.

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SOURCE Eli Lilly and Company
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