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FDA approves Baxter’s norepinephrine injection for treating low blood pressure

September 23, 2021 By Sean Whooley

BaxterBaxter (NYSE:BAX) announced today that it received FDA approval for its premix norepinephrine bitartrate in 5% dextrose injection.

Deerfield, Illinois-based Baxter launched the norepinephrine injection following the approval for raising blood pressure in adult patients with severe, acute hypotension (low blood pressure).

According to a news release, the company’s formulation of norepinephrine is the first and only manufacturer-prepared, ready-to-use formulation. The company offers the formulation in 4 mg/250 mL (16 mcg/mL) and 8 mg/250 mL (32 mcg/mL) strengths.

Norepinephrine offers a treatment for patients experiencing life-threatening hypotension that can occur during certain medical conditions or surgical procedures, as well as acute or emergent hypotension. Baxter’s formulation 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.

“In a critical care situation, speed, efficiency and safety are of the utmost priority,” Baxter GM of U.S. hospital products Heather Knight said in the release. “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.”

Filed Under: Business/Financial News, Cardiovascular, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals, Regulatory/Compliance Tagged With: Baxter, FDA

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at swhooley@wtwhmedia.com.

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