Resources for Food and Drug Administration (FDA)

FDA Approves Supplemental New Drug Application For Antihypertensive Agent Avalide In Patients With Hypertension - Update

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Pharmaceutical companies Sanofi- aventis (SNY) and Bristol-Myers Squibb Co. (BMY) on Monday said the U.S. Food and Drug Administration approved the supplemental new drug application for the antihypertensive agent Avalide for initial use in patients with hypertension who are likely to need multiple drugs to achieve their blood pressure goals.

The companies noted that the approval was based on data from two clinical trials that involved over 1,200 patients with moderate or severe high blood pressure. In the first double-blind, active-controlled, seven-week trial, involving patients with severe hypertension, patients were randomly treated with either Avalide 150/12.5 mg or irbesartan 150 mg monotherapy.

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