FDA Approves Baxter's FLEXBUMIN 5%, First And Only 5% Human Albumin Solution In A Flexible Container

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DEERFIELD, Ill.--(BUSINESS WIRE)--Aug. 4, 2014-- Baxter International, Inc. (NYSE:BAX) today 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.

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Disclosure: I am long on Mannkind.

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