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Lilly Withdraws Yentreve NDA One Day Ahead Of Expected Negative Review

This article was originally published in The Pink Sheet Daily

Executive Summary

Company withdraws its application for the stress urinary incontinence treatment one day ahead of FDA's action date. Discussions with FDA suggested the agency was "not prepared at this time" to approve duloxetine for SUI. NDA withdrawal comes the day after Lilly discussed expected challenges of the Yentreve launch.
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