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FDA issues second approvable letter for Lilly's Cymbalta for the treatment of depression

INDIANAPOLIS, IND., October 1, 2003 -- The FDA has issued a second approvable letter for Cymbalta (duloxetine HCl, a potent serotonin and norepinephrine reuptake inhibitor, said Eli Lilly and Company. Approval is contingent upon resolution of manufacturing issues at Lilly's Indianapolis facilities, including a pre-approval site inspection, and the completion of label negotiations.

"This second approvable letter is good news because it confirms that Cymbalta can be approved without any additional studies," said Sidney Taurel, Lilly's chairman, president and chief executive officer. "The successful resolution of manufacturing issues in Indianapolis, and ultimately rebuilding world-class manufacturing and quality capabilities, remains one of Lilly's top priorities."

Lilly received an approvable letter for Cymbalta in September 2002 noting satisfactory resolution of manufacturing issues and label negotiations as the contingencies for approval. On September 3, 2003, Lilly also announced receipt of an approvable letter for another indication for the duloxetine molecule, stress urinary incontinence (SUI). Final approval for the SUI indication is contingent upon successful completion of additional acute pre-clinical and clinical pharmacology studies, satisfactory resolution of manufacturing issues and label negotiations.

Cymbalta is believed to affect the levels of two key neurotransmitters involved in depression -- serotonin and norepinephrine -- both implicated in the complex spectrum of major depression symptoms. Prozac and many other common antidepressants, in contrast, affect only serotonin.

Source: Lilly

Posted: October 2003