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news.Baxter International has received approval from the US Food and Drug Administration (FDA) for Flexbumin [Albumin (Human)], USP, 5% Solution, for hypovolemia, hypoalbuminemia due to general causes, burns and in patients undergoing cardiopulmonary bypass surgery.
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The FDA approval expands the company’s Flexbumin product portfolio to include both 5% in a 250mL solution and 25% in 50 and 100mL solutions.
Flexbumin is the first and only preparation of human albumin to be packaged in a flexible plastic container, while its new 5% solution will be available to US customers later in 2014.
According to the company, the Flexbumin flexible, shatterproof container provides better safety features for hospitals and reduces risk of glass breakage as well as affords the ability to infuse without a vented administration set.
Additionally, Flexbumin 5% solution offers efficiency features for healthcare professionals through its streamlined three-step administration process, lighter weight and reduced space requirements compared to glass containers of equal volume.
Baxter BioTherapeutics business head Ron Lloyd said human albumin is essential for hospitals in providing care to surgical, trauma and other critically ill patients.
"Our customers value the benefits of having this treatment available in a flexible container that more efficiently meets their needs for reduced waste and improved safety," Lloyd said.
Flexbumin uses the company’s GALAXY flexible container, a proprietary multi-layer system that helps maintain albumin quality and allows the solution to be stored at room temperature.