FDA Approves Bolus Vial Format for Medicure’s Aggrastat
September 1, 2016—Medicure Inc. announced that it has received approval from the US Food and Drug Administration (FDA) for its new "bolus vial" product format for Aggrastat (tirofiban HCl). The newly approved product format is a concentrated, premixed, 15-mL vial designed specifically for convenient delivery of the Aggrastat bolus dose of 25 mcg/kg.
Commercial release of the bolus vial will take place at the beginning of the fourth quarter of this year.
According to the company, development of the bolus vial was in response to feedback from interventional cardiologists and catheterization lab nurses from across the United States.
Aggrastat is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome. Aggrastat is available through the company’s subsidiary, Medicure Pharma, Inc.