Indevus Additional Sanctura QT Study Raised Last Minute Concerns At FDA
This article was originally published in The Pink Sheet Daily
Executive Summary
Although the study confirmed the lack of QT prolongation with the incontinence drug, it brought up the issue of T-wave inversions in the last months of the review cycle, FDA documents indicate. Indevus conducted the additional QT study in response to FDA’s request for new analysis of existing QT data because of “current climate” at the agency.