DEERFIELD (dpa-AFX) - The U.S. Food and Drug Administration or FDA has approved Baxter International, Inc.'s (BAX) FLEXBUMIN, USP, 5% Solution. FLEXBUMIN 5% is indicated for hypovolemia, hypoalbuminemia due to general causes, burns and in patients undergoing cardiopulmonary bypass surgery.
This approval extends Baxter's FLEXBUMIN product portfolio to comprise 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 would 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. FLEXBUMIN makes use of 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.
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