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To review the efficacy and safety data and the challenges of simultaneous development and approval of an agent with more than one indication. During 2004–2005 duloxetine is expected to be approved nearly simultaneously worldwide for two separate indications, major depressive disorder (MDD) in men and women, and stress urinary incontinence (SUI) in women.Data were reviewed from three published double-blind, randomised controlled studies and one published open label study in the treatment of MDD, four published double-blind, randomised controlled studies in the treatment of female SUI, and one high-dose clinical pharmacology study.In men and women with MDD, duloxetine was shown to separate from placebo in four of six studies with an estimated remission ranging from 43% to 57%. In women with SUI, significant median decreases of at least 50% in incontinence episodes and significant improvements in quality of life were observed. A broadly similar side-effect profile was seen for both indications. The most common adverse events in the studies were nausea, insomnia, fatigue and somnolence. Urinary retention was not reported significantly more often in men and women than placebo, and there did not seem to be a risk of mania in non-depressed women with incontinence. No clinically significant safety concerns were seen at higher doses of duloxetine in the clinical pharmacology study.The data reviewed suggest that the availability of duloxetine for more than one indication should not cause undue concerns for patients or prescribing physicians, and the molecule may provide effective treatment options for men and women with depression and for women with stress urinary incontinence.