Pharmacia & Upjohn reboxetine
Executive Summary
User fee date for the norepinephrine reuptake inhibitor extended three months to July 28 following submission of additional data to FDA. Phase III data from reboxetine clinical trials was presented during the American Psychiatric Association annual meeting. Data show that the mean reduction in Hamilton Depression Scale total scores for patients in the reboxetine arm was 19.2 compared to a 16.8 HAM-D reduction for fluoxetine (Lilly's Prozac)