Myxredlin FDA approval : US health care company Baxter International has secured approval from the US Food and Drug Administration (FDA) for Myxredlin (Insulin Human in 0.9% Sodium Chloride Injection), a ready-to-use insulin for IV infusion.
Myxredlin is approved for use as a short-acting human insulin to enhance glycemic control in adults and pediatric patients having diabetes mellitus. The insulin is intended for use in only acute care settings under medical supervision.
According to Baxter, Myxredlin has 30 days of extended shelf life at room temperature or 24 months if refrigerated in the original carton away from light.
Myxredlin is offered in a standardized concentration of 100 units per 100 mL in a flexible plastic container, said the US health care company. Baxter, further said that the packaging of the insulin helps in delivering a consistent, stable and predictable concentration with every dosing, which is a major consideration for patient safety.
Robert Felicelli – president of Baxter Pharmaceuticals said: “Insulin is in the top five drug classes involved with medication errors, and more than 30 percent of those errors result in patient harm.
“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 utilizes Baxter’s Galaxy container technology. A non-PVC and non-DEHP system, Galaxy helps premixed medicines to have a longer shelf life when stored at room temperature.
Baxter plans to launch Myxredlin in the US before the year-end