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Yentreve NDA withdrawal (correction)

Executive Summary

Lilly maintains that a QT prolongation signal was not a factor in the firm's decision to withdraw its application for the stress urinary incontinence therapy Yentreve (duloxetine), as suggested in a 1story in the Feb. 27 issue of "The Pink Sheet" regarding Booz Allen's first-cycle review report. According to review documents for duloxetine in treatment of depression, approved under the trade name Cymbalta, FDA's Division of Reproductive & Urologic Drug Products was concerned that duloxetine may have the potential to prolong the QT interval in patients receiving CYP2D6 and CYP1A2 inhibitors. The division felt the issue needed to be addressed pre-approval due to the common use of CYP2D6 and CYP1A2 inhibitors in the SUI population. Lilly says the withdrawal was due to Yentreve's risk/benefit ratio...

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