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Bayer Gamunex immunoglobulin

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Bayer's intravenous human immunoglobulin Gamunex clears FDA Aug. 27 for primary humoral immunodeficiency and to raise platelet counts in idiopathic thrombocytopenic purpura to prevent bleeding. Bayer is touting its differentiated manufacturing process. For IGIV products, "the specifics of the manufacturing process, such as Bayer [Biological Products'] caprylate/chromatography purification, have a direct impact on the quality of an IGIV product," the firm said. FDA has previously advised healthcare providers to disregard manufacturer statements suggesting superiority of certain IGIV products over others...
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