FDA approves Ready-to-Use Cardiovascular Medication Bivalirudin for Baxter

Baxter asserted the approval of U.S. Food and Drug Administration for Bivalirudin in 0.9 percent Sodium Chloride Injection (bivalirudin). 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).

Robert Felicelli, president, Pharmaceuticals, Baxter said “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 aid the preparation process and can avoid potential errors that may occur when medications are compounded.

Image Source: Baxter