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Cymbalta for chronic pain

Executive Summary

Eli Lilly submits supplemental new drug application in the second quarter for Cymbalta (duloxetine) in the management of chronic pain, the firm announces May 29. With an expected 10-month review, the drug's likely PDUFA timeframe would be February to March 2009. The drug was approved for acute and maintenance treatment of major depressive disorder Nov. 30; it is also approved for acute treatment of generalized anxiety disorder and management of diabetic peripheral neuropathic pain, all in adults 18 and older. An sNDA for use of the drug in fibromylagia is under FDA review, with an expected PDUFA data in June



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