JUL 21, 2026 · REGULATORY APPROVAL
FDA approval: Pitolisant Hydrochloride
U.S. Food and Drug Administration
FDA approval of pitolisant hydrochloride oral tablets; this is a regulatory action record that does not contain clinical trial efficacy or safety data.
Reported
Approval date2026-07-21
Formulation strength 14.45 mg base
Formulation strength 217.8 mg base