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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Regulatory Round-Up: Drug Review Profiles From 2012
Each month, Pharmaceutical Approvals Monthly analyzes the FDA review process for a recent approval based on the NDA or BLA review documents. A detailed chronology of product development and listing of key reviewers accompany each profile.
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