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Lilly files supplemental NDA for Cymbalta

Eli Lilly and Company has submitted a supplemental new drug application to the FDA seeking approval for a new indication for Cymbalta for the management of chronic pain.

The submission is based on outcomes of clinical trials in chronic osteoarthritis pain of the knee and chronic low back pain, in addition to data from previously completed pain studies in diabetic peripheral neuropathic pain and fibromyalgia.

Cymbalta was studied in chronic pain of at least moderate severity in adults who required daily treatment for an extended period of time.