Medicure has submitted an application to the US Food and Drug Administration (FDA) for the introduction of a new “bolus vial” product format for tirofiban hydrochloride monohydrate (HCl), trade name Aggrastat.
The new product format is a concentrated, pre-mixed, 15ml vial containing sufficient drug to administer the FDA-approved, high dose bolus (HDB) of 25mcg/kg at the beginning of treatment. tirofiban HCl is currently only sold in a pre-mixed intravenous bag format that comes in two sizes, 100ml and 250ml. The existing, pre-mixed products will continue to be available, providing a convenient concentration for administering the post-HDB maintenance infusion of 0.15 mcg/kg/min.
Albert Friesen, chief executive officer and president at Medicure, states, “If the application is approved, we anticipate the launch of the new product format in Q3 2016.”
Although the current bag format can be used to deliver the HDB as well as the maintenance infusion, some physicians and hospital catheterisation labs prefer to administer the initial bolus dose with a smaller volume of drug product. Moreover, the availability of a ready-to-use bolus vial should provide greater operational similarities and efficiencies for hospitals transitioning to tirofiban HCl.
The launch of the new product format is dependent upon approval by the FDA, which is expected to take four months.