Cymbalta User Fee Date Extended; Lilly Still Expects Summer Launch
This article was originally published in The Pink Sheet Daily
Executive Summary
Duloxetine now has a late September FDA action date, triggered by Lilly’s submission of new data analyses to support depression indication.
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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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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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