Rozerem FDA 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 timeline for Rozerem
| Date | Article |
|---|---|
| Jul 22, 2005 | Approval Rozerem Takeda Pharmaceuticals North America, Inc. - Treatment for Insomnia |
| Sep 24, 2004 | Takeda Submits New Drug Application for Ramelteon, an Investigational Sleep Drug |
Further information
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