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. 


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Cardiac Interventions Today (ISSN 2572-5955 print and ISSN 2572-5963 online) is a publication dedicated to providing comprehensive coverage of the latest developments in technology, techniques, clinical studies, and regulatory and reimbursement issues in the field of coronary and cardiac interventions. Cardiac Interventions Today premiered in March 2007 and each edition contains a variety of topics in a flexible format, including articles covering various perspectives on current clinical topics, in-depth interviews with expert physicians, overviews of available technologies, industry news, and insights into the issues affecting today's interventional cardiology practices.