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Biovail Cardizem XL NDA

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Biovail submits NDA for the calcium channel blocker Cardizem XL Aug. 23 for treatment of hypertension. The once-daily, graded-release diltiazem formulation "uses a unique dissolution profile, in conjunction with nighttime dosing, to address the body's typical 24-hour circadian variation in blood pressure," the firm says. In Phase III trials comparing nighttime and daytime administration, evening use resulted in "statistically significant and clinically meaningful reductions in diastolic and systolic blood pressure" between 4 a.m. and 12 noon, "the time of day when patients are at the greatest risk of having an adverse cardiac event," the firm said. Biovail received approval in January 2000 for an earlier generation extended-release diltiazem without nighttime dosing. That formulation was never marketed

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