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Bolus dose of glycoprotein IIb/IIIa inhibitor gains FDA approval

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Medicure announced it has received FDA approval for a premixed bolus dose of its glycoprotein IIb/IIIa inhibitor tirofiban HCI for use in patients with non-ST segment elevation ACS.

According to a press release from the company, the approval was for a concentrated, premixed, 15 mm vial that delivers a 25 mcg/kg dose of tirofiban HCI (Aggrastat).

The product is indicated for reduction of thrombotic CV events, including CV death, MI, refractory angina and repeat cardiac procedures in patients with NSTEACS, according to the release.

The company stated the product will be made available at the beginning of the fourth quarter of 2016.