Baxter gets USFDA nod to Cardiovascular Medicine Eptifibatide

Eptifibatide is a platelet aggregation inhibitor that prevents platelets—specialized blood cells—from sticking together and clotting.

DEERFIELD: Baxter International Inc. a global leader in sterile medication production and delivery, recently announced the U.S. Food and Drug Administration (FDA) approval and launch of ready-to-use eptifibatide. Baxter’s presentation of eptifibatide is the first of its kind available in a flexible container.

"Hospital pharmacists are unsung heroes working behind the scenes to make sure every dose of medication is delivered accurately and on-time to patients," said Robert Felicelli, president, Pharmaceuticals, Baxter.

"By adding more essential premix medicines—like eptifibatide—to Baxter's broad portfolio, we can help support pharmacy efficiency, reduce waste and enhance patient safety," he added.

Eptifibatide is a platelet aggregation inhibitor that prevents platelets—specialized blood cells—from sticking together and clotting. Eptifibatide is indicated for medical treatment of acute coronary syndrome (ACS), a broad term that includes heart attack and other emergency conditions in which the blood supply to the heart is suddenly stopped. Eptifibatide is also indicated for treatment of patients undergoing percutaneous coronary intervention (PCI), in which physicians insert a catheter to visualize and open blocked coronary arteries and may if needed, implant a mesh tube, called a stent, to keep the artery open.

Like other medicines in Baxter's premix portfolio, eptifibatide uses Baxter’s proprietary GALAXY container technology. GALAXY is a non-PVC and non-DEHP system that enables premixed medicines to have a longer shelf life when stored at room temperature. Premixed formats of standard doses of commonly prescribed drugs offer efficiencies for hospitals by simplifying the preparation process. Premixes may also help enhance patient safety by avoiding potential dosing errors that may occur when medications are compounded, the process of combining different drug agents in specific quantities to fill individualized prescriptions.

Baxter premixed drugs are formulated to adhere to strict Current Good Manufacturing Practice (cGMP) regulations established and monitored by the FDA. Eptifibatide is currently available from Baxter in the United States.

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