Thursday, March 26, 2009

FDA Approves Olanzapine, Fluoxetine HCl for Treatment-Resistant Depression

The US Food and Drug Administration (FDA) has approved olanzapine and fluoxetine HCl (Symbyax) capsules for the indication of acute treatment of treatment-resistant depression (TRD) in adult patients who have not responded to 2 separate trials of different antidepressants of adequate dose and duration in their current episode.

An 8-week randomised, double-blind, controlled study evaluated the efficacy of olanzapine and fluoxetine HCl in patients (n=300) who met the fourth edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for major depressive disorder (MDD) and did not respond to 2 antidepressants of adequate dose and duration in their current episode.

READ MORE @ DOCTOR'S GUIDE

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