IGIV Manufacturer Letters Should Be Ignored During FDA Review, Agency Says
Executive Summary
Prescriber letters sent by immune globulin intravenous manufacturers asserting superiority over other IGIV products should be disregarded while FDA completes its safety review of thrombotic events, the agency said
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Bayer Gamunex approved
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)...