ASTRAZENECA SUBMITS NEW DRUG APPLICATION FOR TOPROL-XL

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AstraZeneca has submitted a new drug application to the FDA for a new product for the management of hypertension. The product is a combination of Toprol-XL (metoprolol succinate extended-release) and the thiazide diuretic hydrochlorothiazide.

Toprol-XL is already approved as a treatment for hypertension administered alone and/or in combination with other agents. Additional approved indications include the long-term treatment of angina pectoris, and the treatment of stable, symptomatic heart failure of ischemic, hypertensive, or cardiomyopathic origin. In heart failure, the drug was studied in patients already receiving ACE inhibitors, diuretics, and, in the majority of cases, digitalis. Toprol-XL will continue to be available for the treatment of these conditions.

Since many hypertensive patients require combination therapy in order to reach optimal blood pressure levels, combining two effective agents into a single drug product may simplify multidrug treatment regimens.