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Article: FDA Approved ROZEREM(TM) (ramelteon), First and Only Non-Scheduled Prescription Sleep Medication.
- Article from:
- PR Newswire
- Article date:
- July 22, 2005
CopyrightCOPYRIGHT 2005 PR Newswire Association LLC. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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New option is the first prescription insomnia medication with a novel therapeutic mechanism of action in 35 years
LINCOLNSHIRE, Ill., July 22 /PRNewswire/ -- 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 FDA approval allows physicians to prescribe ROZEREM for long-term use in adults.
ROZEREM is the first and only prescription sleep medication that has shown no evidence of abuse and dependence and, as a result, has not been ...