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Drug Development

NDA submitted to U.S. FDA for advanced prostate cancer drug

Published in Cancer Weekly, February 8th, 2005

Abbott (ABT) announced that it has submitted a New Drug Application (NDA) for its oral agent Xinlay (atrasentan) to the U.S. Food and Drug Administration (FDA) seeking approval of Xinlay for the treatment of metastatic hormone-refractory prostate cancer, an advanced stage of the disease that no longer responds to hormone treatment and has spread to other parts of the body, such as the bone.

"The submission of this New Drug Application is an important milestone in Abbott's commitment to prostate cancer patients and their families," said John Leonard, MD, vice president, Global Pharmaceutical Development at Abbott. "Our novel pipeline for drug development has the...

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