FDA approves new Baxter medication

Baxter International Inc., a global leader in sterile medication production and delivery, Monday announced the U.S. Food and Drug Administration approval of a medication used in a common nonsurgical procedure to treat blocked or narrowed blood vessels in the heart.

The FDA approved Bivalirudin in 0.9 percent Sodium Chloride Injection. Bivalirudin is a specific and direct thrombin inhibitor indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention.

"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, based in Deerfield. "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 regulations established and monitored by the FDA. Bivalirudin is expected to launch in the U.S. early this year 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).