FDA approves new bolus vial form of tirofiban hydrochloride
The FDA approved a bolus vial form of tirofiban hydrochloride (Aggrastat) on Sept. 1.
Medicure, which manufactures and markets tirofiban hydrochloride, said in a news release that the company developed the new product format after hearing from interventional cardiologists and catheterization laboratory nurses.
The new format is a concentrated, pre-mixed, 15 ml vial designed to deliver a 25 mcg/kg bolus dose of tirofiban hydrochloride. The drug will be available in the fourth quarter of this year, according to Medicure.
The FDA has approved tirofiban hydrochloride to reduce the combined endpoint of death, MI or refractory ischemia/repeat cardiac procedures in patients with non-ST elevation acute coronary syndrome.