Baxter (BAX) Announces U.S. FDA Approval and Launch of Ready-to-use Cardiovascular Medicine Norepinephrine in Premix Formulation

Baxter International Inc. (NYSE: BAX), a global leader in sterile medication production and delivery, today announced the U.S. Food and Drug Administration (FDA) approval and commercial launch of premix Norepinephrine Bitartrate in 5% Dextrose Injection (norepinephrine). Norepinephrine is indicated to raise blood pressure in adult patients with severe, acute hypotension (low blood pressure). Baxter’s formulation of norepinephrine is the first and only manufacturer-prepared ready-to-use formulation and is available in 4 mg/250 mL (16 mcg/mL) and 8 mg/250 mL (32 mcg/mL) strengths. Please see Important Risk Information and link to full Prescribing Information below.

“In a critical care situation, speed, efficiency and safety are of the utmost priority,” said Heather Knight, general manager, U.S. Hospital Products, Baxter. “Our ready-to-use formulation of norepinephrine allows hospitals to store this medication closer to patient care settings like the emergency department, intensive care unit and surgical areas, letting them administer it faster while reducing the risk of compounding errors or touch contamination.”

Leading voices on guidelines for medication safety—including the Institute for Safe Medication Practices (ISMP) and American Society of Health-System Pharmacists (ASHP)—encourage the use of “commercially prepared, premix parenteral products” versus products that are manually compounded, which is the process of combining different drug agents in specific quantities to fill individualized prescriptions. They also encourage the use of standard concentrations for safety and efficiency reasons.1,2

The use of premixes, or ready-to-use formats of standard doses of commonly prescribed drugs, may offer operational efficiencies in the hospital pharmacy. Compounding a drug for patient use is a multi-step, manual process that requires oversight by pharmacy staff. Using a ready-to-use product can simplify the preparation process and may also help enhance patient safety by avoiding potential dosing errors that may occur when medications are compounded on site.

Norepinephrine is used to treat patients with life-threatening hypotension that can occur during certain medical conditions or surgical procedures as well as acute or emergent hypotension. Baxter’s formulation of norepinephrine has a shelf life of up to 21 months in a refrigerator, or up to 90 days at room temperature in overwrap and can be stored in automated dispensing cabinets at the point-of-care. Norepinephrine uses Baxter’s proprietary VIAFLO container technology, which is not made with natural rubber latex, PVC or DEHP.

Baxter ready-to-use drugs are manufactured in accordance with FDA regulations governing Current Good Manufacturing Practices (cGMP). Norepinephrine is currently available from Baxter in the United States.

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