Second Cymbalta "approvable"
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Lilly's serotonin/norepinephrine reuptake inhibitor Cymbalta (duloxetine) is "approvable" Sept. 29. FDA's second approvable letter for the antidepressant cites manufacturing issues at Indianapolis site. Duloxetine has also been deemed approvable for stress urinary incontinence (1Pharmaceutical Approvals Monthly Sept. 1, 2003, p. 6)...
Lilly's serotonin/norepinephrine reuptake inhibitor Cymbalta (duloxetine) is "approvable" Sept. 29. FDA's second approvable letter for the antidepressant cites manufacturing issues at Indianapolis site. Duloxetine has also been deemed approvable for stress urinary incontinence (1 (Also see "October NME User Fee Lineup Includes Solifenacin, Darifenacin" - Pink Sheet, 1 Sep, 2003.), p. 6).... |