Baxter International Nabs FDA Approval for Insulin IV Infusion

Myxredlin product from Baxter International

Illinois-based Baxter International received the green light from the U.S. Food and Drug Administration (FDA) for its insulin infusion treatment, Myxredlin.

This morning, Baxter announced the FDA approved Myxredlin (Insulin Human in 0.9% Sodium Chloride Injection), as the first and only ready-to-use insulin for IV infusion in the hospital and other acute care settings. Additionally, Myxredlin features an extended shelf life of 30 days at room temperature, or up to two years if refrigerated in the original carton to protect the medication from light, the company said. Myxredlin is indicated for use as short-acting human insulin to improve glycemic control in adults and pediatric patients with diabetes mellitus. Myxredlin is intended for use only in acute care settings under medical supervision.

Myxredlin uses Baxter’s Galaxy container technology. Galaxy enables premixed medicines to have a longer shelf life when stored at room temperature. Premixed and ready-to-use formats of standard doses of commonly prescribed drugs offer efficiencies for hospitals by simplifying the preparation process. For Myxredlin, the technology helps ensure the medication “delivers a consistent, stable and predictable concentration with every administration, which is a key consideration for patient safety,” the company said.

Robert Felicelli, president of Pharmaceuticals at Baxter International, said insulin is one of the most common drug classes that is involved with medication errors. More than 30% of those errors result in patient harm, he added.

“When a patient requires intravenous insulin in the hospital, pharmacists have to manually admix insulin for treatment. With the launch of Myxredlin, clinicians will have access to a convenient, reliable presentation of ready-to-use insulin that can help ensure faster delivery to patients, streamlined workflow for pharmacists and nurses, and less waste for hospitals,” Felicelli said in a statement.

Myxredlin is expected to be available in the United States before the end of the year.

The approval of Myxredlin comes only a few months after the FDA approved Baxter’s ready-to-use cardiovascular medication, eptifibatide. Eptifibatide is a platelet aggregation inhibitor that prevents platelets 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 technology.

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