Treats excessive daytime sleepiness (EDS). ANDA 218846, held by Lupin. Pitolisant Hydrochloride.
As of Nov 15, 2026, ANDA 218846 (Pitolisant Hydrochloride), held by Lupin, was first approved by FDA on Aug 14, 2026, with 0 approved supplements and 0 published complete response letters.
Pitolisant Tablets are indicated for the treatment of excessive daytime sleepiness (EDS) in patients with narcolepsy. Pediatric use information is approved for Harmony Biosciences Management Inc.'s WAKIX (pitolisant) tablets. However, due to Harmony Biosciences Management Inc.'s marketing exclusivity rights, this drug product is not labeled with that information.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 14, 2026 | Original application | Approved | None posted |
| Pitolisant HydrochlorideEQ 4.45MG BASE · tablet;oral | Pitolisant Hydrochloride | Rx |
| Pitolisant HydrochlorideEQ 17.8MG BASE · tablet;oral | Pitolisant Hydrochloride | Rx |
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
