Rozerem Approval History
FDA Approved: Yes (First approved July 22, 2005)
Brand name: Rozerem
Generic name: ramelteon
Dosage form: Tablets
Company: Takeda Pharmaceuticals North America, Inc.
Treatment for: Insomnia
Rozerem (ramelteon) is an orally active hypnotic indicated for the treatment of insomnia characterized by difficulty with sleep onset.
Development History and FDA Approval Process for Rozerem
|Jul 22, 2005||Rozerem Takeda Pharmaceuticals North America, Inc. - Treatment for Insomnia|
|Sep 24, 2004||Takeda Submits New Drug Application for Ramelteon, an Investigational Sleep Drug|
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