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Approvals In Brief

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Takeda's Rozerem sleep aid to debut in September: Insomnia agent Rozerem (ramelteon) will launch in September after receiving FDA approval July 22, Takeda says. Indicated for "treatment of insomnia characterized by difficulty with sleep onset," Rozerem will be marketed by more than 1,000 reps highlighting its melatonin receptor activity and lack of abuse potential, the company says. Rozerem is the first MT-1/MT-2 melotonin agonist approved for insomnia. The leading insomnia therapies - Sanofi-Aventis' Ambien (zolpidem), Sepracor's Lunesta (eszopiclone) and King's Sonata (zaleplon) - target the gamma-aminobutyric acid receptor complex. Takeda notes that Rozerem is unique in that "all other prescription medications indicated for insomnia are classified as Schedule IV controlled substances" by the Drug Enforcement Administration (1Pharmaceutical Approvals Monthly February 2005, p. 10)...

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