FDA Approves New Acetaminophen Injections in Multiple Doses


The injection bags will be available in 1000 mg in 100 mL doses, as well as in 500 mg in 50 mL doses.

FDA, Injections, surgery

The US Food and Drug Administration (FDA) has approved the first and only Acetaminophen Injection flexible PAB IV Bags available in multiple doses.

The approval, awarded to B Braun Medical, is earmarked for the injections in both 1000 mg in 100 mL and 500 mg in 50 mL doses in bags not made with PVC, DEHP, or latex.

"With the approval of Acetaminophen Injection, we are pleased to offer healthcare providers a safe, effective and affordable treatment option," said Angela Karpf, MD, Corporate Vice President of Medical Affairs, in a statement. "The convenient PAB IV container, which is not made with PVC, DEHP or latex, adds another layer of safety for patients, healthcare workers and the environment."

The company uses dual-sourced Active Pharmaceutical Ingredients (API) to mitigate potential supply risk.

"Acetaminophen Injection is the first of multiple injectable drugs B. Braun plans to launch in the coming years to help meet the needs of patients for medications in high demand," said Leigh Nickens, Director of Marketing, Fluid Therapy & Injectable Drugs, in a statement. "It represents our commitment to improve the security of supply by manufacturing pharmaceuticals in the United States at our newly expanded and modernized facility in Irvine, California."

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