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New Drug Application for Tolvaptan, Otsuka's Investigational Novel Oral Treatment for Worsening Heart Failure and Hyponatremia, Accepted by the U.S. Food and Drug Administration
Date:12/21/2007

iving tolvaptan vs. 3.9% in patients receiving placebo). For all of these, the number of patients that received tolvaptan was 2063 and for placebo was 2055 in addition to standard of care.

About Heart Failure

More than 14 million people in Europe(3) and five million U.S. residents(4) have heart failure (HF), a serious chronic condition in which the heart cannot effectively pump blood. Hospitalizations in the United States related to HF account for 75 percent of the $46 billion spent each year on the care of HF patients, according to the American Heart Association.(5) The majority of patients hospitalized for worsening HF, about 1 million U.S. residents annually, have edema or excess body fluid.

About Hyponatremia

Hyponatremia, characterized by low concentrations of sodium in the blood, is a known predictor of death in patients with serious underlying illnesses.(6) Hyponatremia has long been associated with neurological symptoms including in its worst forms seizure and coma, and in its mildest forms slowed thoughts and reflexes.(7) Normal serum sodium is between 135 to 145 mEq/L, whereas patients diagnosed with hyponatremia have sodium levels of less than 135 mEq/L.(8)

About Otsuka Pharmaceutical Development & Commercialization, Inc.

Otsuka Pharmaceutical Development & Commercialization (OPDC) is involved in conducting all phases of clinical research and development of innovative healthcare products to address unmet medical needs. OPDC is well established in the scientific community as a globally focused organization that plays a leadership role in the research and development of Otsuka's ethical healthcare products. The Company is dedicated to the improvement of the quality of human life and health of patients around the world with a strong commitment to research and development in the areas of cardiovascular, neuroscience, renal and respiratory diseases, as well as cancer and ophthalmic disorders. The Company is part of the
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SOURCE Otsuka Pharmaceutical Development & Commercialization,Inc.
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