Bystolic correction
Executive Summary
A recent article on the approval of Forest/Mylan's Bystolic (nebivolol) incorrectly reported that it was the combination trial of Bystolic submitted in the NDA that established a different efficacy profile in black subjects; it was actually a trial published in the November 2007 issue of the Journal of Clinical Hypertension that found Bystolic to significantly reduce sitting diastolic and systolic blood pressure as monotherapy among blacks with stage I-II hypertension (1"The Pink Sheet" Jan. 7, 2008, p. 5)...