FDA approves Baxter's FLEXBUMIN solution
Baxter International, Inc. announced that the United States Food and Drug Administration (FDA) has approved FLEXBUMIN [Albumin (Human)], USP, 5% Solution. FLEXBUMIN 5% is indicated for hypovolemia, hypoalbuminemia due to general causes, burns and in patients undergoing cardiopulmonary bypass surgery.
This approval expands Baxter’s FLEXBUMIN product portfolio to include both 5% in a 250 mL solution and 25% in 50 and 100 mL solutions. FLEXBUMIN is the first and only preparation of human albumin to be packaged in a flexible plastic container. The new FLEXBUMIN 5% solution will be available to U.S. customers later this year.
The FLEXBUMIN flexible, shatterproof container offers unique safety features for hospitals by eliminating risk of glass breakage and affords the ability to infuse without a vented administration set. In addition, FLEXBUMIN 5% solution provides 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, making it more compatible with hospital inventory storage systems.
''Human albumin is essential for hospitals in providing care to surgical, trauma and other critically ill patients,'' said Ron Lloyd, head of Baxter’s BioTherapeutics business. ''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.''
FLEXBUMIN uses Baxter’s GALAXY® flexible container, a proprietary multi-layer system that helps maintain albumin quality and allows the solution to be stored at room temperature. The GALAXY container, which employs barrier technology and a continuous aseptic filling process, has been used in the United States for more than 16 years to package pharmaceutical products. The flexible infusion system allows for simple administration steps with a non-vented administration set. Compared with glass bottles of equal volume, shipping containers for FLEXBUMIN 5% contain approximately 45% less packaging materials and empty containers are 95% lighter, resulting in less waste.