General MedicationsORALStandard
WAKIX
PITOLISANT HYDROCHLORIDE
Standard Dose
EQ 4.45MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary
Approval overview WAKIX is listed in Drugs@FDA under application 211150 (NDA).
Review priority: PRIORITY Marketing status: Prescription Active ingredient PITOLISANT HYDROCHLORIDE Form and strength TABLET;ORAL - EQ 4.45MG BASE Sponsor HARMONY Submission history Latest submission status date: 2026-02-13 00:00:00.
Structured Monograph
Clinical summary
Approval overview WAKIX is listed in Drugs@FDA under application 211150 (NDA). Review priority: PRIORITY Marketing status: Prescription Active ingredient PITOLISANT HYDROCHLORIDE Form and strength TABLET;ORAL - EQ 4.45MG BASE Sponsor HARMONY Submission history Latest submission status date: 2026-02-13 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: PRIORITY
Interaction Notes
- No interaction notes stored yet.