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.
Cymbalta is the best thing that I have ever tried and for more than just depression. I also suffered from debilitating anxiety. Both have all but disappeared. Before I started taking it about 4 months ago I literally hoped I would just fade away. I wanted to die so badly it's all I thought about. I have lost 45 pounds along with my compulsive overeating disorder and have gained more peace and happiness than I ever knew could exist for me. It saved my life (and helped me be a much better mother, wife, daughter-everything). I will deal with the super sweatiness and a few extra yawns during my day in order to have a life. Viva la Cymbalta!