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Merck’s Suvorexant rouses insomnia but must outperform generics to shine

This article was originally published in Scrip

Executive Summary

On 8 November, the FDA accepted for standard review an NDA application for suvorexant; Merck’s potential first-in-class treatment for insomnia. The candidate will be evaluated by the FDA’s Controlled Substance Staff during NDA review, and if approved, will become available after a schedule assessment and determination has been completed by the US Drug Enforcement Administration. Suvorexant is an orexin receptor antagonist and therefore represents a novel mechanism of action in the insomnia pipeline.

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