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Home Industry News AstraZeneca seeks NDA approval for hypertension combo

AstraZeneca seeks NDA approval for hypertension combo

4th November 2005

AstraZeneca has announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for a new hypertension treatment. The drug will combine previously approved blood pressure treatment Toprol-XL and the thiazide diuretic hydrochlorothiazide (HCT).

As many hypertensive patients require combination therapy to effectively reduce blood pressure, AstraZeneca says that combining two agents known to be effective will simplify treatment regimes. The NDA submission is based on the clinical results of a US study of 1,571 hypertensive patients treated with the combination, amongst other research.

Toprol-XL is already approved in the US for hypertension treatment, administered alone or 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 cases it was studied in patients already receiving diuretics and ACE inhibitors and in most cases digitalis. Hydrochlorothiazide is a thiazide diuretic, contraindicated in patients with anuria and in patients who are hypertensive to any component of this product or to other sulphonamide derived treatment.

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