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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

Otsuka Pharmaceutical Group, which is comprised of 99 companies and approximately 31,000 people around the world. Otsuka and its consolidated subsidiaries earned US $7.2 billion in consolidated annual revenues in fiscal 2006. For additional information, please visit http://www.otsuka.com.

1. Current Proposed PLR, October 19, 2007. Page 1. Supplied by Otsuka.

2. EVEREST, SALT-1, SALT-2

3. SHAPE Survey Results to the General Public, Annual Congress of the

European Society of Cardiology in Vienna, September 2003.

4. ACC News Release, "American College of Cardiology / American Heart

Association guidelines: New heart failure guidelines stress early diagnosis and treatment," August 16, 2005. Accessed at http://www.acc.org/media/releases/highlights/2005/aug05/hf%5Fguideline%5Fupdate.ht m on March 1, 2007.
5. American Heart Association. Heart Disease and Stroke Statistics:

2005Update. Dallas, Tex: American Heart Association; 2005. as cited in

Gheorghiade M, et al. Circulation. 2005;112:3958-3968.

6. Schrier RW, Gheorghiade M, Gross P, et al. Results from the SALT 1 and

2 Trials. Multicenter, Randomized, Placebo-Controlled Trials in

Patients with Euvolemic and Hypervolemic Hyponatremia. Being Presented

at American Heart Association's Scientific Sessions in November 2006.

7. Adrogue HJ, Madias NE. Hyponatremia. NEJM. 2000; 342 (21):1581-1589.

8. Gheorghiade M, Gottlieb SS, Udelson JE, et al. Vasopressin V2 Receptor

Blockade With Tolvaptan Versus Fluid Restriction in the Treatment of

Hyponatremia. AmJCardiol 2006;97:1064-1067.


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SOURCE Otsuka Pharmaceutical Development & Commercialization,Inc.
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