Baxter International has announced the U.S. Food and Drug Administration (FDA) approval of Bivalirudin in 0.9 percent Sodium Chloride Injection (bivalirudin). Bivalirudin is a specific and direct thrombin inhibitor indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI), a common non-surgical procedure to treat blocked or narrowed blood vessels in the heart.
“The approval of bivalirudin demonstrates how Baxter brings its innovative technologies together with medicines in ways that help promote efficiency for clinicians,” said Robert Felicelli, president, Pharmaceuticals, Baxter. “Baxter’s presentation of this widely used cardiovascular medication is the first and only available in a convenient frozen premixed solution.”
Bivalirudin will use Baxter’s proprietary frozen GALAXY container technology, a non-PVC and non-DEHP system specifically designed to create a ready-to-use format for unstable molecules. Premixed versions of commonly prescribed drugs help simplify the preparation process and can avoid potential errors that may occur when medications are compounded. Compounding is the process of combining different ingredients in specific quantities to fill individualized prescriptions.
Baxter’s premixed medications are manufactured to current Good Manufacturing Practice (cGMP) regulations established and monitored by the FDA. Bivalirudin is expected to launch in the United States in early 2018 in two commonly prescribed dosage forms and strengths: 250 mg of bivalirudin per 50 mL (5 mg/mL) and 500 mg of bivalirudin per 100 mL (5 mg/mL).