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Takeda’s Sleep Aid Rozerem Could Avoid Controlled Substance Scheduling, Firm Says

This article was originally published in The Pink Sheet Daily

Executive Summary

The insomnia agent ramelteon uses a different mechanism of action than Sanofi-Aventis’ Ambien and Sepracor’s Lunesta, both of which are Schedule IV substances. Rozerem NDA is pending at FDA with a July 22 user fee date.

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