Takeda Gets FDA Approval for New Sleeping Pill
Posted on: Monday, 25 July 2005, 09:01 CDT
Jul. 23--TOKYO -- Takeda Pharmaceutical Co. said Saturday its U.S.-based research and development center has received approval from the U.S. Food and Drug Administration for a new prescription insomnia medicine.
Rozerem, which is generically known as ramelteon and comes in 8-milligram tablets, is the first product of its kind that has shown no evidence of abuse and dependence and therefore has not been designated as a controlled substance by the Drug Enforcement Administration, the major Japanese pharmaceutical company said.
Takeda will market it in the United States through its U.S. unit, it said, without giving a timetable.
According to Takeda, ramelteon treats insomnia by specifically affecting the activity of neurons in an area of the brain involved in the sleep-wake process.
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Source: Kyodo News International, Tokyo
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