Bayer HealthCare announced that a reformulation of the liquid Leukine (sargramostim) 500 mcg vial has been approved by the United States Food and Drug Administration (FDA) and is now available for patients and physicians in the US. The new formulation does not contain EDTA (edetate disodium), which was used in the product's liquid 500 mcg vial manufactured from January 2006 to January 2008.
In January 2008, Bayer withdrew the previously marketed liquid Leukine 500 mcg vial 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 Leukine to include EDTA in 2006.
The details can be read here.
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