B. Braun Receives the First and Only FDA Approval for Acetaminophen Injection in Multiple Doses
BETHLEHEM, PA – February 25, 2021 – B. Braun Medical Inc. (B. Braun), a leader in infusion therapy and pain management, today announced that they have received approval from the U.S. Food & Drug Administration for the first and only Acetaminophen Injection available in multiple doses.
Acetaminophen Injection, manufactured by B. Braun in Irvine, California, is available in our sturdy, flexible PAB® IV Bags in both 1,000 mg in 100 mL and 500 mg in 50 mL doses. Our PAB® IV bags are 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. “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."
B. Braun’s Acetaminophen Injection is manufactured using dual-sourced Active Pharmaceutical Ingredients (API) to mitigate potential supply risks. ”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 “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.”
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF MEDICATION ERRORS AND HEPATOTOXICITY
Take care when prescribing, preparing, and administering Acetaminophen Injection to avoid dosing errors which could result in accidental overdose and death. In particular, be careful to ensure that:
- the dose in milligrams (mg) and milliliters (mL) is not confused;
- the dosing is based on weight for patients under 50 kg;
- infusion pumps are properly programmed; and
- the total daily dose of acetaminophen from all sources does not exceed maximum daily limits.
Acetaminophen Injection contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed the maximum daily limits, and often involve more than one acetaminophen-containing product.
INDICATIONS AND USAGE
Acetaminophen Injection is indicated for
- the management of mild to moderate pain in adult and pediatric patients 2 years and older
- the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older
- the reduction of fever in adult and pediatric patients.
Acetaminophen is contraindicated:
- in patients with known hypersensitivity to acetaminophen or to any of the excipients in the intravenous formulation.
- in patients with severe hepatic impairment or severe active liver disease
About B. Braun
B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pennsylvania and is part of the
B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap® and CAPS®.
Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, explore our website.