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Bayer Announces Availability of Reformulated Liquid Leukine(R)
Date:5/19/2008

- EDTA removed from product -

WAYNE, N.J., May 19 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals Inc. announced today that a reformulation of the liquid Leukine(R) (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 U.S. The new formulation does not contain EDTA (edetate disodium), which was in the product's liquid 500 mcg vial manufactured from January 2006 to January 2008.

"The reintroduction of liquid sargramostim without EDTA is welcome news to oncologists and hematologists," said Mark Heaney, MD, PhD, Associate Attending Physician, Memorial Sloan-Kettering Cancer Center, New York, NY, who has studied the biology of the receptor of this drug for more than a decade. "Sargramostim has an important role in reducing life-threatening infections and early death due to infections among older adults (> 55 years of age) with acute myelogenous leukemia (AML). Further, sargramostim is an important therapy in cancer supportive care and has a proven survival benefit in patients experiencing bone marrow transplant failure or engraftment delay."

In January 2008, Bayer withdrew the previously marketed liquid Leukine 500 mcg vial from the U.S. market in order to reformulate it to eliminate EDTA in light of an increase in spontaneous reporting of certain labeled 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. With the approval and relaunch of liquid Leukine in a non-EDTA formulation, Bayer is closing a special access program that reserved priority access to lyophilized Leukine 250 mcg vials, which do not contain EDTA, for patients with the greatest medical need. Sufficient supply of the new, non-EDTA liquid and lyophilized formulations of Leukine is now available to meet cancer care mar
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SOURCE Bayer HealthCare Pharmaceuticals Inc.
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