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Hetlioz FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 28, 2021.

FDA Approved: Yes (First approved January 31, 2014)
Brand name: Hetlioz
Generic name: tasimelteon
Dosage form: Capsules
Company: Vanda Pharmaceuticals Inc.
Treatment for: Non-24-Hour Disorder; Smith-Magenis Syndrome Sleep Disturbance

Hetlioz (tasimelteon) is a melatonin receptor agonist for the treatment of Non-24-Hour Disorder in adults, and nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older.

Development timeline for Hetlioz

Dec  1, 2020Approval FDA Approves Hetlioz (tasimelteon) for the Treatment of Nighttime Sleep Disturbances in Smith-Magenis Syndrome
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

Further information

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