Rozerem Approval History

  • FDA approved: Yes (First approved July 22nd, 2005)
  • Brand name: Rozerem
  • Generic name: ramelteon
  • 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.

FDA Approval History for Rozerem

DateArticle
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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