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Drug Development

New drug application submitted for Toprol-XL and thiazide combination tablets for hypertension

Published in Drug Week, December 16th, 2005

AstraZeneca (AZN) announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for a new product for the management of hypertension.

The product is a combination of Toprol-XL (metoprolol succinate extended-release (ER) and the thiazide diuretic, hydrochlorothiazide (HCT).

Toprol-XL is already approved in the United States 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 (NYHA Class II or III) heart failure of ischemic, hypertensive, or...

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