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www.fdanews.com/articles/86682-lilly-submits-cymbalta-supplemental-new-drug-application

LILLY SUBMITS CYMBALTA SUPPLEMENTAL NEW DRUG APPLICATION

May 9, 2006

Eli Lilly has announced the recent submission of a supplemental new drug application (sNDA) to the FDA for Cymbalta (duloxetine HCl) for the treatment of generalized anxiety disorder.

Cymbalta is already approved in the U.S. for the treatment of major depressive disorder and the management of diabetic peripheral neuropathic pain, both in adults. Lilly is also conducting Phase III studies on Cymbalta and its effects on fibromyalgia, a chronic, often debilitating pain disorder characterized by widespread muscle aches, pain and stiffness in muscles, and often accompanied by fatigue and sleep disturbance.