FDA Approves Ready-to-Use Bivalirudin Formulation
Baxter announced that the Food and Drug Administration (FDA) has approved its ready-to-use Bivalirudin in 0.9% Sodium Chloride Injection.
Bivalirudin is indicated as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI). Baxter's formulation marks the first frozen premixed solution for bivalirudin. The product utilizes the Company's proprietary GALAXY container technology, which consists of a non-PVC and non-DEHP system creating a ready-to-use format for unstable molecules. Premixed formulations can help simplify the preparation process and avoid errors associated with compounding medications.
Bivalirudin, a specific and direct thrombin inhibitor, binds both to the catalytic site and to the anion-binding exosite of circulating and clot-bound thrombin. The binding of bivalirudin to thrombin is reversible as thrombin slowly cleaves the bivalirudin-Arg3-Pro4 bond, resulting in recovery of thrombin active site functions.
Bivalirudin injection for intravenous (IV) use will be supplied as 250mg/50mL and 500mg/100mL strengths and is anticipated to be available in early 2018.
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