Baxter Secured FDA Approval for IV Insulin

| By | FDA, insulin
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Baxter International has secured approval from the US Food and Drug Administration (FDA) for its Myxredlin (insulin human in 0.9% sodium chloride injection).

Myxredlin is claimed to be the first and only ready-to-use insulin for intravenous (IV) infusion in the hospital and other acute care settings.

It is provided with an expanded 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 available in a standardised concentration of 100units/100mL in a flexible plastic container.

It is designated for use as short-acting human insulin to enhance glycemic control in adults and paediatric patients with diabetes mellitus. It is intended for use only in acute care settings under medical supervision.

Myxredlin uses the Galaxy container technology similar to multiple other medicines in Baxter’s portfolio of premix and ready-to-use injectables.

Galaxy is Baxter’s non-PVC and non-DEHP system, which provides a longer shelf life to the premixed medicines when stored at room temperature.

Premixes and ready-to-use formulations will also help improve patient safety by through avoiding potential errors or potential contamination that may result when medications are admixed or compounded.

The company plans to launch Myxredlin in the UD by the end of this year.

Baxter pharmaceuticals president Robert Felicelli 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.

Baxter supplies a range of generic injectable medicines, including difficult-to-manufacture oncology drugs and standard-dose, ready-to-use premixed injectable anti-infectives, analgesics and critical care medicines.

SOURCE: PBR
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