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GlaxoSmithKline Coreg expands indications

This article was originally published in Pharmaceutical Approvals Monthly

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Executive Summary

Labeling for GlaxoSmithKline's beta blocker Coreg (carvedilol) is revised Nov. 1 to add claim for treatment of severe heart failure. Approval was based on data from the Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) trial, which found Coreg "reduced the risk of death in patients with severe heart failure by 35% compared to placebo," GSK says. Coreg was already approved for mild to moderate heart failure

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