Symbyax (olanzapine and fluoxetine HCl, from Lilly) capsules have been FDA approved for the acute treatment of treatment-resistant depression (TRD). The approvals for TRD were based on data from clinical studies that demonstrated Symbyax and combination Zyprexa and fluoxetine therapy resulted in statistically significantly greater reductions in mean total Montgomery Asberg Depression Rating Scale (MADRS) scores from baseline compared to fluoxetine or olanzapine monotherapy.

In addition, the FDA approved two new combination indications for Lilly’s Zyprexa (olanzapine) and fluoxetine for the acute treatment of bipolar depression and TRD in adults. This approval was based on data which showed statistically significantly greater reductions in MADRS scores from baseline with the combination compared to Zyprexa monotherapy or placebo.

In addition to the new indications, Lilly has updated the Symbyax and Zyprexa product labels to include additional information regarding weight gain, hyperglycemia, and hyperlipidemia following the FDA’s review of clinical trial data submitted by Lilly.

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