hetlioz
Generic: tasimelteon
hetlioz: developed by 1 company · 2 FDA decisions. Updated within the last hour.
Development Pipeline (1)
| Company | Phase |
|---|---|
| Vanda Pharmaceuticals Inc. (VNDA) | Approved |
FDA Decisions
FDA_MeetingThe FDA concluded that the sNDA for HETLIOZ for the treatment of jet lag disorder cannot be approved in its current form.(VNDA)
Approval1 INDICATIONS AND USAGE HETLIOZ is a melatonin receptor agonist. HETLIOZ capsules are indicated for the treatment of: Non-24-Hour Sleep-Wake Disorder (Non-24) in adults ( 1 ) Nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older ( 1 ) HETLIOZ LQ oral suspension is indicated for the treatment of: Nighttime sleep disturbances in SMS in pediatric patients 3 years to 15 years of age ( 1 ) 1.1 Non-24-Hour Sleep-Wake Disorder (Non-24) HETLIOZ capsules are i(VNDA)
Frequently asked questions
Who is developing hetlioz?
hetlioz is being developed by Vanda Pharmaceuticals Inc..
What is hetlioz's latest FDA decision?
The most recent tracked FDA decision for hetlioz is FDA_Meeting for The FDA concluded that the sNDA for HETLIOZ for the treatment of jet lag disorder cannot be approved in its current form., dated January 7, 2026.
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