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Lilly Announces Updates to the Zyprexa and Symbyax U.S. Labels
Date:10/5/2007

INDIANAPOLIS, Oct. 5 /PRNewswire-FirstCall/ -- Eli Lilly and Company announced today that as a part of on-going discussions with the U.S. Food and Drug Administration (FDA), the company has updated the Zyprexa(R) (olanzapine) and Symbyax(R) (olanzapine and fluoxetine HCl) U.S. product labels. This new labeling information is available at http://www.Zyprexa.com and http://www.Symbyax.com.

The updates reflect recently completed pooled analyses of Lilly's clinical trial data in adults and adolescents(1), information from two large non-Lilly studies of atypical antipsychotics (CATIE and CAFE) and discussions with the FDA. Specifically, the changes include new warnings for weight gain and hyperlipidemia (elevation of triglycerides and cholesterol) and updated information in the warning for hyperglycemia (elevated blood sugar), including additional language on a greater association of increases in glucose levels with olanzapine than with some other atypical antipsychotics. Lilly continues to work with the FDA and will provide additional data and analyses as they become available.

"Today's communication is part of Lilly's historical and ongoing commitment to inform doctors and patients about updated prescribing information," said Sara Corya, M.D., global medical director, Lilly. "Zyprexa is an important treatment option for patients suffering from the devastating effects of schizophrenia and bipolar disorder, as is Symbyax for patients with bipolar depression. This information will continue to help healthcare professionals evaluate and make the best treatment decisions for individual patients," she added.

Information on the potential risks of weight gain and elevations in blood sugar and lipids already exists in the Zyprexa and Symbyax labels. These meta- bolic changes and weight gain have been reported as adverse events since Zyprexa's approval in
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