ASTRAZENECA SUBMITS NEW DRUG APPLICATION FOR TOPROL-XL
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.
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