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Novartis’ blood pressure drug approved at higher doses

The FDA has approved two new, higher dose formulations of Novartis' high blood pressure medication Diovan HCT.

The approval of the higher strengths of the drug provides additional options that could help physicians more effectively manage their patients’ high blood pressure. Novartis said that the new formulations will be commercially available by early June 2006.

Diovan HCT is a combination of the blood pressure medicine Diovan (valsartan), the most prescribed agent in the angiotensin receptor blocker (ARB) class, and the diuretic hydrochlorothiazide (HCTZ).

Data supporting approval showed the new higher doses of Diovan HCT provided significantly greater reductions in blood pressure compared to either therapy alone. Diovan HCT 320/25mg lowered systolic/diastolic blood pressure 25/17mmHg, compared to 6/7mmHg with placebo alone.

“Millions of patients already rely on Diovan and Diovan HCT to help them get to goal and maintain healthier blood pressure levels,” said Alex Gorsky, head of pharma, North America and CEO of Novartis Pharmaceuticals. “The approval and availability of these new formulations means that, with Diovan HCT, physicians will have the widest and most flexible range of dosing options in the ARB class.”