# PITOLISANT
> **ANDA218495** · Abbreviated New Drug Application (Generic) · Sponsor: NOVITIUM PHARMA LLC · Approved 2026-03-24
## Drug
- **FDA Application Number:** ANDA218495
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** PITOLISANT
- **Generic name:** Pitolisant
- **Active ingredients:** PITOLISANT
- **Dosage form:** TABLET
- **Route:** —
- **Marketing status:** None (Tentative Approval)
- **Sponsor:** NOVITIUM PHARMA LLC
- **First approval:** 2026-03-24
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218495)
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*MORVS · CC0 1.0*