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CV Therapeutics: FDA to review additional use of angina drug

Fri Dec 7, 2007 7:45am EST

Dec 7 (Reuters) - CV Therapeutics Inc CVTX.O said U.S. health regulators will evaluate the approval for potential anti-arrhythmic claims for its angina drug, Ranexa, as part of its review for an additional use of the drug.

Stocks  |  Regulatory News

This follows the U.S. Food and Drug Administration's acceptance of a supplemental new drug application seeking approval of Ranexa as a first-line treatment for chronic angina and request for a "significant reduction in cautionary language" in its label.

Ranexa is currently indicated for the treatment of chronic angina in patients who have not achieved an adequate response with other antianginal drugs, and should be used in combination with amlodipine, beta-blockers or nitrates. (Reporting by Neha Pathania in Bangalore; Editing by Amitha Rajan)



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