Medicure Applies to FDA for Approval of New Aggrastat Format

May 11, 2016—Medicure Inc. announced that it has submitted an application to the US Food and Drug Administration (FDA) for the introduction of a new “bolus vial” product format for Aggrastat (tirofiban hydrochloride). The new product format is a concentrated, premixed, 15-mL vial containing sufficient drug to administer the FDA-approved, high-dose bolus (HDB) of 25 μg/kg at the beginning of treatment.

The launch of the new product format is dependent upon approval by the FDA. Expected FDA review time is 4 months. If the application is approved, Medicure Inc. anticipates the launch of the new product format in the third quarter of 2016.

The company noted that Aggrastat is currently sold only in a premixed intravenous bag format that comes in two sizes, 100 mL and 250 mL. The existing, premixed products will continue to be available to provide a convenient concentration for administering the post-HDB maintenance infusion of 0.15 μg/kg/min.

Medicure advised that although the current bag format can be used to deliver the HDB as well as the maintenance infusion, some physicians and hospital catheterization labs prefer to administer the initial bolus dose with a smaller volume of drug product. Additionally, the availability of a ready-to-use bolus vial will provide greater operational similarities and efficiencies for hospitals transitioning to Aggrastat.

As with the existing bag format, the new Aggrastat bolus vial does not require refrigeration and has a relatively neutral acidity (pH, 5.5–6.5). 

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 nonST-elevation acute coronary syndrome. The dosage instruction is to administer 25 μg/kg intravenously within 5 minutes and then 0.15 μg/kg/min for up to 18 hours. In patients with creatinine clearance ≤ 60 mL/min, administer 25 μg/kg within 5 minutes and then 0.075 μg/kg/min, advised Medicure Inc.