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FDA Approves Valsartan for Treatment of High Blood Pressure in Children

East Hanover, NJ, December 3, 2007 - Diovan (valsartan), an angiotensin receptor blocker or ARB, has been approved following a priority review by the US Food and Drug Administration (FDA) for the treatment of high blood pressure in children and adolescents ages six to 16.

High blood pressure has become a multigenerational health issue. Thirty percent of American adults are currently living with high blood pressure and now there are reports that nearly five percent of children and adolescents may have this condition.

Experts suggest that the increase in incidence of high blood pressure among children and adolescents is linked to the growing pediatric obesity epidemic. Based on the National Health and Nutrition Surveys (NHANES), the percentage of overweight children (6 to 11 years old) increased from 13.8% to 16.0% between 1999 and 2004, while the share of overweight adolescents (12 to 19 years old) rose from 14.0% to 18.2% during the same period.

"Novartis believes it is important to provide physicians with treatment options such as Diovan which are effective in treating high blood pressure in this vulnerable population of children and adolescents," said John Orloff, MD, Senior Vice President, Medical and Drug Regulatory Affairs, Novartis Pharmaceuticals Corporation.

No relevant differences were identified between the adverse experience profile for pediatric patients aged six to 16 and that previously reported for adult patients. Diovan is not indicated for treatment in children under six years old.

About Diovan
Clinical studies have shown that Diovan effectively lowers blood pressure. Diovan specifically blocks a hormone that causes arteries to constrict (tighten and narrow), an action that can cause high blood pressure.

In adults, Diovan is indicated for the treatment of hypertension when used alone or in combination with other high blood pressure agents. Diovan is also indicated for the treatment of heart failure (NYHA class II-IV). In clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction, Diovan is indicated to reduce cardiovascular mortality.

Source: Novartis

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