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Takeda's Rozerem Will Not Be First-Line Competitor To Ambien, Sanofi Says

This article was originally published in The Pink Sheet Daily

Executive Summary

Rozerem (ramelteon) launch could open a new segment of sleep aid market; Sanofi-Aventis predicts the insomnia agent's different mechanism of action will prevent it from competing directly with Ambien. Company is readying launch of Ambien CR to counter increased competition.

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Takeda's Rozerem To Launch In September Following FDA Approval

Ramelteon clears FDA for "treatment of insomnia characterized by difficulty with sleep onset." Takeda is positioning Rozerem as the only prescription insomnia agent that does not carry controlled substance scheduling.

Takeda's Rozerem To Launch In September Following FDA Approval

Ramelteon clears FDA for "treatment of insomnia characterized by difficulty with sleep onset." Takeda is positioning Rozerem as the only prescription insomnia agent that does not carry controlled substance scheduling.

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

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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