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Approval application withdrawn by Eli Lilly


INDIANAPOLIS Eli Lilly and Co. has withdrawn an application seeking approval from the Food and Drug Administration to market its antidepressant Cymbalta for treating chronic pain, the Indianapolis-based drug maker said Friday.

Citing a need for more data, Lilly said it plans to resubmit the application in the first half of next year for the added use of the drug.

“This was a difficult decision, but we believe the updated data package will give the FDA a broader basis for reviewing our application,” vice president of Lilly Research Laboratories John Hayes said in a statement.

Cymbalta (duloxetine hydrochloride) is already approved for treating depression, anxiety disorder, diabetic peripheral neuropathic pain and fibromyalgia.

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