Vivus' Qnexa Gets "Complete Response" Letter From FDA
This article was originally published in The Pink Sheet Daily
Executive SummaryFDA wants more data on risk of birth defects, cardiovascular effects, but doesn't ask for new clinical trials - at least for now.
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Arena’s Belviq is the first obesity drug approval in over a decade, but it won’t be the only one for long. A look at the FDA-approved labeling for lorcaserin offers a preview of how the agency could handle similar issues for Qnexa and, further down the line, Contrave.
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