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| | FDA Approved ROZEREM(TM) (ramelteon), First and Only Non-Scheduled Prescription Sleep Medication : ArriveNet Press ... (Site not responding. Last check: 2007-10-15) |
 | | LINCOLNSHIRE, IL -- (Market Wire - Jul 22, 2005) -- Takeda Pharmaceuticals North America, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for ROZEREM(TM) (ramelteon) 8-mg tablets for the treatment of insomnia characterized by difficulty with sleep onset. |
 | | The ROZEREM NDA, submitted in September 2004 by Takeda Global Research and Development Center, Inc., was based on data collected from an extensive clinical research program, including recently completed clinical studies with more than 4,200 patients ages 18 to 93. |
 | | In the United States, Takeda currently markets oral diabetes, insomnia, and cholesterol-lowering treatments, and through the Takeda Global Research and Development Center, Inc., the company has a robust pipeline with compounds in development for diabetes, cardiovascular disease, and other conditions. |
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