duloxetine

Lilly receives approvable letter

The US FDA has issed an approvable letter for Lilly’s dual 5HT/noradrenaline reuptake inhibitor, duloxetine (CYMBALTA), for the treatment of depression. The letter also states that approval is contingent upon labelling requirements and resolution of outstanding manufacturing issues. The NDA for this indication was submitted November 2001. A US phase III trial for the treatment of stress urinary incontinence has been completed by Lilly and a regulatory filing for this indication is predicted fourth quarter 2002.

Lead Story from Drug News, 27 Sept 2002.

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