Baxter Wins US FDA Approval of Myxredlin, The First and Only Ready-To-Use Insulin for IV Infusion
25 July 2019 - - The US Food and Drug Administration has approved Myxredlin (Insulin Human in 0.9% Sodium Chloride Injection), US-based sterile medication production and delivery specialist Baxter International Inc. (NYSE: BAX) said.
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.
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 individualised prescriptions.
Baxter premix and ready-to-use drugs are formulated to adhere to strict Current Good Manufacturing Practice 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.
Baxter provides a wide range of high-value generic injectable medicines that help treat some of the most pressing healthcare needs facing patients, including difficult-to-manufacture oncology drugs and standard-dose, ready-to-use premixed injectable anti-infectives, analgesics and critical care medicines.
Baxter has rapidly expanded its pharmaceuticals portfolio through recent acquisitions, strategic partnerships and internal development programmes that will help increase access to essential medicines and advance pharmacy efficiency and patient care.
Baxter is also the first and only company to offer all three of the most commonly used modern inhaled anesthetics for general anesthesia.
Every day, millions of patients and caregivers rely on Baxter's leading portfolio of critical care, nutrition, renal, hospital and surgical products.
For more than 85 years, we've been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers that make it happen.
With products, technologies and therapies available in more than 100 countries, Baxter's employees worldwide are now building upon the company's rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations.
Myxredlin is a short-acting human insulin indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.