Pitolisant Hydrochloride · Regulatory approval

FDA approval: Pitolisant Hydrochloride

U.S. Food and Drug Administration · July 21, 2026

Regulatory Update Why this matters to you Expert discussion

An action by a regulator. Authoritative on labelling and availability.

AI Summary

The FDA approved pitolisant hydrochloride (Novitium Pharma) as an oral tablet formulation in two strengths on 21 July 2026. This is a regulatory action record and does not include clinical trial outcomes, efficacy data, or safety results; readers should consult the full prescribing information and published clinical evidence to assess the drug's clinical role.

What was studied

Regulatory approval. Intervention: Pitolisant hydrochloride oral tablets, 4.45 mg base and 17.8 mg base.

Key findings

FDA approval granted 2026-07-21 for pitolisant hydrochloride oral tablets (4.45 mg and 17.8 mg base equivalents)

Safety

This regulatory record does not contain clinical trial results, efficacy data, or comparative safety information.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

FDA approval of pitolisant hydrochloride oral tablets; this is a regulatory action record that does not contain clinical trial efficacy or safety data.

Study design

As stated by the source record.

InterventionPitolisant hydrochloride oral tablets, 4.45 mg base and 17.8 mg base

Reported figures

Quoted from the source exactly as published.

Approval date2026-07-21

Formulation strength 14.45 mg base

Formulation strength 217.8 mg base

Caveats

This regulatory record does not contain clinical trial results, efficacy data, or comparative safety information.
The indication(s) for use are not stated in this record; consult the FDA label and prescribing information.
No trial design, sample size, endpoints, or outcome measures are reported.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

insufficient

This is a regulatory action, not a clinical study.

Directness

insufficient

No clinical endpoints or comparative evidence reported in this record.

Consistency

insufficient

Single regulatory approval; no comparative data provided.

Risk of bias

insufficient

Not applicable to regulatory approval record.

Sample adequacy

insufficient

No clinical trial population described in this record.

Source abstract

Drugs@FDA record for application ANDA218495. This is a regulatory action record, not a clinical study. Brand name: PITOLISANT HYDROCHLORIDE. Active ingredient: PITOLISANT HYDROCHLORIDE. Sponsor: NOVITIUM PHARMA. Submission type: ORIG (original application). Approval status date: 2026-07-21. Products: PITOLISANT HYDROCHLORIDE, TABLET, ORAL, PITOLISANT HYDROCHLORIDE EQ 17.8MG BASE; PITOLISANT HYDROCHLORIDE, TABLET, ORAL, PITOLISANT HYDROCHLORIDE EQ 4.45MG BASE.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Novitium PharmaPitolisant Hydrochloride