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Duloxetine Drug Interactions Are Issue For Yentreve, But Not For Cymbalta

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA’s neuropharm and urology review divisions hold differing opinions on duloxetine drug interactions, Cymbalta review documents indicate. Due to potential QT risk, urology division delays Yentreve approval for stress urinary incontinence; neuropharm division believes potential QT effect can be considered post-approval.

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Cymbalta was launched for depression in August; Lilly anticipates first half 2005 approval of duloxetine for stress urinary incontinence under the Yentreve name. Patent challenges to the antipsychotic Zyprexa and Lilly’s cost-cutting efforts are also likely topics at the investor meeting.

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