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Belviq Gains FDA Approval For Weight Loss, But DEA Review Will Delay Launch

This article was originally published in The Pink Sheet Daily

Executive Summary

With a July 17 user fee date, Vivus’ obesity drug Qnexa could beat Arena Pharmaceuticals’ Belviq to the marketplace as lorcaserin awaits controlled substance scheduling by the Drug Enforcement Agency.

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The obesity drug market will see substantial commercial investment in the second half of 2013. Vivus is planning its first DTC advertising for Qsymia and continuing its search for a big pharma partner, while Eisai/Arena have been cleared by the Drug Enforcement Agency to launch Belviq.

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The summary report of an interim analysis of the ongoing LIGHT clinical trial evaluating the cardiovascular safety of the obesity medicine can form the basis of a resubmission of the Contrave NDA, the company announced, shaving some time off the PDUFA clock.

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