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news.Takeda Pharmaceutical Company has submitted a new drug application of ramelteon for treatment of insomnia to the Ministry of Health, Labour and Welfare in Japan.
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Ramelteon was approved by the FDA in July 2005 as the first and only prescription sleep medication, classified non-controlled substance, showing no evidence of abuse and dependence. It is being marketed by Takeda Pharmaceuticals North America under the trade name Rozerem.
Masaomi Miyamoto, general manager of Pharmaceutical Development Division of Takeda, said: “Ramelteon has a novel mechanism of action different from currently existing medicines for insomnia. We look forward to offering a new treatment option for insomnia.”