Ready-To-Use Insulin for IV Infusion Granted FDA Approval
The drug is indicated for use as a short-acting human insulin to improve glycemic control in adults and pediatric patients with diabetes mellitus. It is only intended to use in acute care settings under medical supervision.
Baxter has announced FDA approval of its insulin human in 0.9% sodium chloride Injection (Myxredlin), a ready-to-use insulin for IV infusion.
The product is indicated for use as a short-acting human insulin to improve glycemic control in adults and pediatric patients with diabetes mellitus. It is only intended to use in acute care settings under medical supervision.
This drug has an extended shelf life of 30 days at room temperature, or 24 months refrigerated. The ready-to-use presentation eliminates the need for admixing and batching, therefore improving safety for patients, according to Baxter. It is available in a standardized concentration of 100 units/100 mL in a flexible plastic container that enables premixed medicines to have a longer shelf life when stored at room temperature.
As the first ready-to-use insulin for IV infusion, Baxter's product helps provide a consistent, stable concentration with every administration. This not only improves patient safety, but will help streamline workflow for pharmacists and nurses in acute care settings.
“Insulin is in the top 5 drug classes involved with medication errors, and more than 30% of those errors result in patient harm,” said Robert Felicelli, president of pharmaceuticals at Baxter, in a prepared statement.
Contraindications for the medication include use during episodes of hypoglycemia and use in patients with hypersensitivity to insulin human or any of the excipients.
The drug is expected to be available in the United States by the end of the year.
This approval is the newest addition to Baxter’s portfolio of generic injectable medications including oncology drugs and standard-dose, ready-to-use premixed injectable anti-infectives, analgesics, and critical care medicines.
Baxter Announces U.S. FDA Approval of Myredlin, the First and Only Ready-to-use Insulin for IV Infusion [news release]. Deerfield, IL; July 22, 2019: Baxter. https://www.baxter.com/baxter-newsroom/baxter-announces-us-fda-approval-myxredlin-first-and-only-ready-use-insulin-iv. Accessed July 22, 2019.