To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Reformulated Liquid Sargramostim Now Available in the US URL: http://www.pslgroup.com/dg/221A6A.htm Doctor's Guide May 20, 2008
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.