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.
You may also be interested in...
Ambien CR Gets FDA Approval; Launch Expected In Mid-September
Sanofi-Aventis' follow-on sleep agent is indicated for insomnia characterized by difficulties in sleep onset or maintenance.
Ambien CR Gets FDA Approval; Launch Expected In Mid-September
Sanofi-Aventis' follow-on sleep agent is indicated for insomnia characterized by difficulties in sleep onset or maintenance.
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.