FDA approves higher dose formulations of Novartis' Diovan HCT for high blood pressure

By Lisa Kerner

Erie, Pa., May 1 - The Food and Drug Administration approved two new, higher dose formulations of Novartis Pharmaceuticals Corp.'s high blood pressure medication Diovan HCT (valsartan/hydrochlorothiazide), 320/12.5 mg and 320/25 mg.

Diovan HCT was previously available in 80/12.5 mg, 160/12.5 mg and 160/25 mg tablets.

The new formulations of Diovan HCT, a combination of the blood pressure medicine Diovan (valsartan) and the diuretic hydrochlorothiazide (HCTZ), will be commercially available by early June.

"Millions of patients already rely on Diovan and Diovan HCT to help them get to goal and maintain healthier blood pressure levels," chief executive officer Alex Gorsky said in a company news release.

"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."

High blood pressure affects more than 65 million Americans, or one in three adults.

The data supporting approval of the Diovan HCT higher dose formulations will be presented at the American Society of Hypertension, Inc. Annual Scientific Meeting and Exposition in New York.

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