Treats Non-24. NDA 205677, held by Vanda Pharms Inc. Tasimelteon.
As of Nov 15, 2026, NDA 205677 (Hetlioz), held by Vanda Pharms Inc, was first approved by FDA on Jan 31, 2014, with 5 approved supplements and 0 published complete response letters.
HETLIOZ is a melatonin receptor agonist. HETLIOZ capsules are indicated for the treatment of: Non-24-Hour Sleep-Wake Disorder (Non-24) in adults Nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older 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 Non-24-Hour Sleep-Wake Disorder (Non-24) HETLIOZ capsules are indicated for the treatment of Non-24 in adults. 1.2 Nighttime Sleep Disturbances in Smith-Magenis Syndrome (SMS) HETLIOZ capsules are indicated for the treatment of nighttime sleep disturbances in SMS in patients 16 years of age and older.
| Dec 1, 2020 | Supplement 7Efficacy (new indication or use) · Priority review | Approved | |
| Jan 31, 2014 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hetlioz20MG · capsule;oral | Tasimelteon | RxReference drug |
| Jul 27, 2026 | Supplement 13Manufacturing | Approved | |
| Dec 1, 2020 | Supplement 7Efficacy (new indication or use) · Priority review | Approved | |
| Oct 7, 2019 | Supplement 6Labeling · Standard review | Approved | |
| Apr 11, 2016 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Dec 12, 2014 | Supplement 1Labeling · Standard review | Approved | |
| Jan 31, 2014 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
