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Bayer Gamunex approved

Executive Summary

Bayer Gamunex human immune globulin I.V. approved by FDA Aug. 27 for primary humoral immunodeficiency and idiopathic thrombocytopenic purpura. The biologic is the first new IGIV product submitted to FDA in more than a decade. In its announcement of the approval, Bayer refers to Gamunex as a "differentiated, next-generation" product and notes that "not all IGIVs are the same." FDA issued a statement in September advising healthcare providers to disregard manufacturer letters suggesting superiority of certain IGIV products over others (1"The Pink Sheet" Sep. 2, 2002, p. 13)...
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