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More threads by David Baxter

David Baxter

Mar 26, 2004
Cymbalta? gets FDA approval for Generalized Anxiety Disorder
Tuesday, 27-Feb-2007

Eli Lilly and Company has announced that the U.S. Food and Drug Administration (FDA) has approved its antidepressant Cymbalta? (duloxetine HCl) for the treatment of generalized anxiety disorder (GAD).

The safety and efficacy of Cymbalta was established in three randomized, double-blind, placebo-controlled studies totaling more than 800 non-depressed adults with GAD. In all three studies Cymbalta significantly reduced core anxiety symptoms as measured by the Hamilton Anxiety Scale (HAMA), compared with placebo.

Cymbalta was studied in a dose range of 60-120 mg per day. While a 120mg/day dose was shown to be effective, there is no evidence that doses greater than 60mg/day confer additional benefit. The target daily dose is 60 mg.

Cymbalta is a duel serotonin and norepinephrine (noradrenaline) reuptake inhibitor (SNRI). It has already been approved for the treatment of major depressive disorder and management of diabetic peripheral neuropathic pain, both in adults. Cymbalta is not approved for use in pediatric patients.


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