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Reformulated Liquid Sargramostim Now Available in the US BERLIN -- May 19, 2008 -- Bayer HealthCare announced today that a reformulation of the sargramostim (Leukine) 500-mcg vial has been approved by the US Food and Drug Administration (FDA) and is now available for patients and physicians in the United States. The new formulation does not contain edetate disodium (EDTA), which was used in the product's liquid 500-mcg vial manufactured from January 2006 to January 2008. In January 2008, Bayer withdrew this product from the US market because of an increase in spontaneous reporting of certain labelled adverse events, including syncope (fainting). The timing of increased reporting of these adverse events coincided with the change in the formulation of liquid sargramostim to include EDTA in 2006. Among its indications, sargramostim is the only myeloid growth factor approved to reduce the incidence of severe and life-threatening infections following induction chemotherapy in older adult patients with acute myelogenous leukemia (AML), and to prolong survival of patients who have undergone allogeneic or autologous bone marrow transplantation (BMT) and are experiencing graft failure or engraftment delay, as compared with historical experience. Sargramostim also has been approved in the United States for peripheral blood stem cell (PBSC) mobilisation and subsequent myeloid reconstitution in patients undergoing PBSC transplantation. Source: Bayer HealthCare E-mail this page to a friend or colleague! To print, use this version