FDA Approves Myxredlin Insulin for IV Infusion

Baxter International announced the U.S. Food and Drug Administration (FDA) approval of Myxredlin (Insulin Human in 0.9% Sodium Chloride Injection). Myxredlin (pronounced mix-RED-lin) is the first and only ready-to-use insulin for IV infusion in the hospital and other acute care settings and features an extended shelf life of 30 days at room temperature (77 degrees F [25 degrees C]) or 24 months if refrigerated (36 degrees F to 46 degrees F [2 degrees C to 8 degrees C]) in the original carton to protect from light. Myxredlin is provided in a standardized concentration of 100 units/100 mL in a flexible plastic container. This innovative presentation helps ensure Myxredlin delivers a consistent, stable and predictable concentration with every administration, which is a key consideration for patient safety.

"Insulin is in the top five drug classes involved with medication errors, and more than 30 percent of those errors result in patient harm," said Robert Felicelli, president, Pharmaceuticals, Baxter. "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."

Myxredlin is indicated for use as a 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.

Like many other medicines in Baxter’s portfolio of premix and ready-to-use injectables, Myxredlin 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 and ready-to-use formats of standard doses of commonly prescribed drugs offer efficiencies for hospitals by simplifying the preparation process. Premixes and ready-to-use formulations may also enhance patient safety by helping to avoid potential errors or potential contamination that may occur when medications are admixed or compounded, the process of combining different drug agents in specific quantities to fill individualized prescriptions.

Baxter premix and ready-to-use drugs are formulated to adhere to strict Current Good Manufacturing Practice (CGMP) regulations established and monitored by the FDA. Myxredlin is expected to be available from Baxter in the United States before the end of the year.

-----------------------------------------------------------------------
Editor's Note:

If you have any suggestion to the content, 

please email: Julia.Zhang@ubmsinoexpo.com