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FDA Clears Belviq With Post Hoc Finding Of Less Than Double Placebo CV Risk

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

In analyses of both a narrow and a broad search for cardiovascular events in lorcaserin’s clinical trials, the upper bound of the 95% confidence level was less than 2.0, allowing marketing with a full CV outcomes trial to come post-approval, FDA briefing documents reveal.

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