Medicure 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 format is a concentrated, pre-mixed, 15ml vial designed specifically for convenient delivery of the drug in a bolus dose (25mcg/kg). A press release reports that the development of the bolus vial was in response to feedback from interventional cardiologists and catheterisation lab nurses from across the USA.
According to the press release, the commercial release of the bolus vial will take place at the beginning of the fourth quarter of this year. The company believes this new product format will have a positive impact on hospital use of Aggrastat.
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 (NSTE-ACS).