approval · primary record
PITOLISANT HYDROCHLORIDE
FDA · NDA · 2026-02-13
| Agency | FDA |
|---|---|
| Submission type | NDA |
| Latest action | 2026-02-13 |
| Approval events | 1 |
| Brand | WAKIX |
| Sponsor | HARMONY |
| Route | ORAL |
Approval history
1 action on record. The drug is the stable record; each action below is an event with its own date, so this URL keeps working as new actions arrive.
| Date | Agency | Type | Brand | Sponsor | Route |
|---|---|---|---|---|---|
| 2026-02-13 | FDA | NDA | WAKIX | HARMONY | ORAL |
Provenance
- Source: openFDA Drugs@FDA
- Fetched at: 2026-10-30T06:30:09.935Z
- Licence class: public-domain
- Verdict: primary-source
- Entity id: approval:pitolisant-hydrochloride
This record is rendered from the AEaH spine. If the source is unreachable the page is not generated.
Same entity, elsewhere in the suite
- Pitolisant Hydrochloride · compound