Treats excessive daytime sleepiness (EDS) or cataplexy. NDA 211150, held by Harmony. Pitolisant Hydrochloride.
As of Nov 13, 2026, NDA 211150 (Wakix), held by Harmony, was first approved by FDA on Oct 13, 2020, with 4 approved supplements and 1 published complete response letter.
WAKIX is indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy in patients 6 years of age and older with narcolepsy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 13, 2026 | Supplement 6Efficacy (new indication or use) · Priority review | Approved | |
| Jun 21, 2024 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| Oct 13, 2020 | Original applicationEfficacy (new indication or use) · Priority review | Approved | |
| Aug 14, 2019 | Original applicationNew molecular entity · Priority review | Approved |
| Letter | Product | Now |
|---|---|---|
| Aug 14, 2019 | Wakix (pitolisant)Clinical, Harmony Ctp, Labeling | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| WakixEQ 4.45MG BASE · tablet;oral | Pitolisant Hydrochloride | RxReference drug |
| WakixEQ 17.8MG BASE · tablet;oral | Pitolisant Hydrochloride | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 13, 2026 | Supplement 6Efficacy (new indication or use) · Priority review | Approved | |
| May 23, 2025 | Supplement 7Labeling · Standard review | Approved | |
| Jun 21, 2024 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| Dec 22, 2022 | Supplement 3Labeling · Standard review | Approved | |
| Oct 13, 2020 | Original applicationEfficacy (new indication or use) · Priority review | Approved | |
| Aug 14, 2019 | 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
