Healthcare Industry News: bivalirudin
News Release - September 1, 2016
FDA Approves New AGGRASTAT(R) Product FormatBolus Vial to Improve Delivery Convenience
WINNIPEG, Sept. 1, 2016 -- (Healthcare Sales & Marketing Network) - Medicure Inc. ("Medicure" or the "Company") (TSXV:MPH, OTC:MCUJF), a specialty pharmaceutical company, announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its new "bolus vial" product format for AGGRASTAT® (tirofiban HCl).
The newly approved product format is a concentrated, pre-mixed, 15 ml vial designed specifically for convenient delivery of the AGGRASTAT bolus dose (25 mcg/kg). Development of the bolus vial was in response to feedback from interventional cardiologists and catheterization lab nurses from across the United States.
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 utilization of AGGRASTAT.
About Medicure Inc.
Medicure is a specialty pharmaceutical company focused on the development and commercialization of therapeutics for the U.S. hospital market. The primary focus of the Company and its subsidiaries is the marketing and distribution of AGGRASTAT (tirofiban HCl) for non-ST elevation acute coronary syndrome in the United States, where it is sold through the Company's U.S. subsidiary, Medicure Pharma, Inc. For more information on Medicure please visit www.medicure.com.
Indications and Usage
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).
Dosage and Administration
Administer intravenously 25 mcg/kg within 5 minutes and then 0.15 mcg/kg/min for up to 18 hours. In patients with creatinine clearance =60 mL/min, give 25 mcg/kg within 5 minutes and then 0.075 mcg/kg/min.
In clinical studies with the HDB regimen, Aggrastat was administered in combination with aspirin, clopidogrel and heparin or bivalirudin to over 8,000 patients for typically =24 hours.
Known hypersensitivity to any component of Aggrastat History of thrombocytopenia with prior exposure to Aggrastat Active internal bleeding, or history of bleeding diathesis, major surgical procedure or severe physical trauma within previous month.
Warnings and Precautions
Aggrastat can cause serious bleeding. If bleeding cannot be controlled discontinue Aggrastat. Thrombocytopenia: Discontinue Aggrastat and heparin.
Bleeding is the most commonly reported adverse reaction.
For more information on AGGRASTAT, please refer to Full Prescribing Information.
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