FDA Approves Baxter's Cardiovascular Drug Norepinephrine In Premix Formulation - Quick Facts

(RTTNews) - Sterile medication producer Baxter International Inc. (BAX) announced Thursday that 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.

Baxter's 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.

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 U.S.