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FDA Issues Not-Approvable Letter for Lilly's Zyprexa(R) Long-Acting Injection (LAI) for Schizophrenia Treatment
Date:2/28/2008

ve sedation, this patient fully recovered.

"We are disappointed by the FDA's decision and we are committed to ongoing discussions to better understand the agency's perspective regarding this recent case of excessive sedation and to define the path forward and the associated timeline," said Dr. Jennifer Stotka, Vice President of U.S. Regulatory Affairs, Eli Lilly and Company. "Given the chronic and severe nature of schizophrenia, persistent challenges with adherence, and the limited number of approved depot formulations, we continue to believe that, if approved, Zyprexa LAI would provide a valuable treatment option for patients suffering from schizophrenia."

Independent regulatory reviews of Zyprexa LAI applications are ongoing in the European Union and other countries including Canada and Australia.

About Long-acting Injectable Antipsychotic Medications

Long-acting antipsychotics have been associated with improved treatment adherence and reduced treatment failures.(i) By administering long-acting medications, healthcare professionals know when patients have received their medication and can immediately detect non-adherence when a patient fails to return for a scheduled injection.(ii) Different from both oral and injected short-acting formulations, long-acting antipsychotics allow for stable concentrations of the active drug to remain at a therapeutic range for an extended period of time.(iii)

About Schizophrenia

Schizophrenia is a severe and debilitating illness often characterized by acute psychotic episodes including delusions (false beliefs that cannot be corrected by reason), hallucinations (usually in the form of non-existent voices or visions) and long-term impairments such as diminished emotion, lack of interest and depressive symptoms, such as hopelessness and suicidal thoughts. In addition to these symptoms, patients with schizophrenia are at greater risk for medical comorbidities than the general population.

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SOURCE Eli Lilly and Company
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