Eli Lilly plans to file supplemental NDA for antidepressant Cymbalta to treat anxiety

By E. Janene Geiss

Philadelphia, Dec. 9 - Eli Lilly and Co. said Friday that it plans to submit a supplemental New Drug Application in 2006 to the Food and Drug Administration for Cymbalta (duloxetine hydrochloride) for the treatment of generalized anxiety disorder.

Lilly said it has completed two clinical trials, which the company believes will support this submission, according to a news release.

"People with generalized anxiety disorder experience a wide array of symptoms from excessive worry to difficulty concentrating. In addition, it is also common for patients to experience physical symptoms like muscle tension, restlessness or fatigue," Michael Detke, Cymbalta medical director, said in the release.

Cymbalta was approved for the treatment of major depression in August 2004, followed by another approval for the management of diabetic peripheral neuropathic pain, also known as diabetic nerve pain, in September 2004.

Eli Lilly is an Indianapolis pharmaceutical company.

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