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Article: FDA clears Biovail's Cardizem LA for the treatment of angina.(Brief Article)
- Article from:
- Pharma Marketletter
- Article date:
- April 12, 2004
CopyrightCOPYRIGHT 2004 Marketletter Publications Ltd. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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The US Food and Drug Administration has approved the use of Canada-based Biovail's hypertension drug, Cardizem LA (diltiazem), for the treatment of chronic stable angina.
Clinical evidence
The company filed the supplemental New Drug Application last year (Marketletter July 14, 2003) which was based on findings from a randomized, double-blind, parallel-group, dose-response trial involving 311 patients with chronic stable angina. In the study, evening doses of 180mg, 360mg and 420mg of Cardizem LA, and 360mg of the drug administered in the morning, were compared to placebo.
Results showed that all doses of Cardizem LA given at night increased ...