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Rozerem Approval History

  • FDA approved: Yes (First approved July 22nd, 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, 2005Approval Rozerem Takeda Pharmaceuticals North America, Inc. - Treatment for Insomnia
Sep 24, 2004Takeda Submits New Drug Application for Ramelteon, an Investigational Sleep Drug

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