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Osteoarthritis
Lilly Resubmits Cymbalta(R) Supplemental New Drug Application for Chronic Pain to U.S. Food and Drug Administration
June 21st, 2009
As projected, Eli Lilly and Company (NYSE:LLY) has resubmitted its supplemental New Drug Application (sNDA) for Cymbalta(R) (duloxetine HCl) for the management of chronic pain to the U.S. Food and Drug Administration (FDA). Lilly's resubmission is based on a recently completed study in chronic pain due to osteoarthritis, the extension phase of a chronic low back pain study and previously completed studies in pain due to osteoarthritis and chronic low back pain. The application is supported by studies in diabetic peripheral neuropathic pain (DPNP) and fibromyalgia. Lilly originally submitted the sNDA in the second quarter of 2008 but withdrew the application in November...
Source: Medical Letter on the CDC & FDA (2009-06-21)
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