AstraZeneca files new drug application for combined Toprol-XL hypertension product

By E. Janene Geiss

Philadelphia, Nov. 1 - AstraZeneca announced Tuesday that it has submitted a New Drug Application to the U.S. Food and Drug Administration for a new product for the management of hypertension.

The application is based in part on the clinical results on the product, a combination of Toprol-XL and thiazide diurectic hydrochlorithiazide (HCT), officials said in a company news release.

The results came from a study of 1,571 hypertension patients taking the combined drug in a U.S., multi-center, randomized, double-blind, placebo-controlled study and examined a wide range of doses, officials said.

Because many hypertension patients require combination therapy in order to reach optimal blood pressure levels, combining two effective agents into a single drug product may simplify multi-drug treatment regimens, official said.

Toprol-XL is already approved in the United States as a treatment for hypertension administered alone and in combination with other agents. It will continue to be available and is used in the treatment of angina pectoris, some types of heart failure and digitalis, officials said.

An estimated 65 million Americans have hypertension, officials said.

AstraZeneca is a London-based pharmaceutical company.

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