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Lilly Submits Cymbalta sNDA for Pain

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Eli Lilly and Co. has submitted a sNDA to the FDA seeking approval for a new indication for Cymbalta (duloxetine HCl) for the management of chronic pain. The submission is based on clinical trial results in chronic osteoarthritis pain of the knee and chronic low back pain, in addition to data from previous studies in diabetic peripheral neuropathic pain (DPNP) and fibromyalgia. Cymbalta was studied in moderate chronic pain in adults who required daily treatment for an extended period of time.
   
Cymbalta is currently approved to treat major depressive disorder, generalized anxiety disorder, and the management diabetic peripheral neuropathic pain.

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