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Hetlioz Approval History

  • FDA approved: Yes (First approved January 31st, 2014)
  • Brand name: Hetlioz
  • Generic name: tasimelteon
  • Dosage form: Capsules
  • Company: Vanda Pharmaceuticals Inc.
  • Treatment for: Non-24-Hour Disorder

Hetlioz (tasimelteon) is a melatonin receptor agonist for the treatment of Non-24-Hour Disorder in the totally blind.

Development History and FDA Approval Process for Hetlioz

Jan 31, 2014Approval FDA Approves Hetlioz: First Treatment for Non-24 Hour Sleep-Wake Disorder in Blind Individuals
Nov 15, 2013FDA Advisory Committee Recommends Approval of Hetlioz for the Treatment of Non-24-Hour-Disorder (Non-24) in the Totally Blind
May 31, 2013Vanda Announces Submission To FDA Of A New Drug Application For Tasimelteon For The Treatment Of Non-24-Hour Disorder In The Totally Blind

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