Methadone Hydrochloride · Regulatory label update

FDA supplemental approval: Methadone Hydrochloride (REMS)

U.S. Food and Drug Administration · June 18, 2026

Regulatory Update Why this matters to you Expert discussion

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

AI Summary

This is an FDA supplemental approval (REMS designation) for methadone hydrochloride oral solution 10 mg/5 mL by Hikma, approved 18 June 2026. The record documents regulatory action only and does not contain clinical trial results, efficacy data, or comparative safety information.

What was studied

Regulatory label update.

Key findings

Safety

No clinical trial results, efficacy, safety data, or comparative outcomes are reported.

Who this may help

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

Plain-language summary

FDA supplemental approval action for methadone hydrochloride REMS; regulatory designation only, not a clinical evidence assessment.

Caveats

This is a regulatory action record, not a clinical trial or evidence synthesis.
No clinical trial results, efficacy, safety data, or comparative outcomes are reported.
REMS designation indicates a Risk Evaluation and Mitigation Strategy but the specific requirements are not detailed in this record.
The source does not provide information on clinical indications, dosing, or patient populations studied.

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 record, not a clinical study.

Directness

insufficient

Record does not report clinical trial outcomes or comparative data.

Consistency

insufficient

No efficacy or safety data provided in this regulatory record.

Risk of bias

insufficient

Not applicable; this is a regulatory action, not a clinical trial.

Sample adequacy

insufficient

No study population or sample size; regulatory approval record only.

What is missing. This record has no key findings, reported figures. That is a gap in the analysis, not a judgement about the study.

Source abstract

Drugs@FDA record for application ANDA087997. This is a regulatory action record, not a clinical study. Brand name: METHADONE HYDROCHLORIDE. Active ingredient: METHADONE HYDROCHLORIDE. Sponsor: HIKMA. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-06-18. Products: METHADONE HYDROCHLORIDE, SOLUTION, ORAL, METHADONE HYDROCHLORIDE 10MG/5ML.

Follow from this

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

HikmaMethadone Hydrochloride