Methadone · 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

The FDA issued a supplemental approval on 18 June 2026 for methadone hydrochloride 10 mg tablets under a Risk Evaluation and Mitigation Strategy (REMS). This is a regulatory action record and does not contain clinical trial results, efficacy data, or comparative evidence.

What was studied

Regulatory label update.

Key findings

FDA supplemental REMS approval for methadone hydrochloride 10 mg tablet formulation (ANDA204166, sponsor VISTAPHARM LLC)

Safety

This is a regulatory action record; it does not report clinical trial results, efficacy, safety data, or comparative effectiveness. FDA supplemental REMS approval for methadone hydrochloride 10 mg tablet formulation (ANDA204166, sponsor VISTAPHARM LLC)

Who this may help

This regulatory record confirms FDA approval of a methadone formulation under REMS requirements. Clinicians should refer to the approved REMS program documentation and product labelling for prescribing guidance; this record itself contains no clinical evidence or outcome data.

Plain-language summary

FDA supplemental approval action for methadone hydrochloride REMS; describes regulatory status only, not clinical trial data or efficacy evidence.

Reported figures

Quoted from the source exactly as published.

Approval date2026-06-18

Application numberANDA204166

Dose approved10 mg

Clinical bottom line

Caveats

This is a regulatory action record; it does not report clinical trial results, efficacy, safety data, or comparative effectiveness.
No information on the specific REMS requirements, rationale, or risk mitigation strategy is provided in this record.
No clinical population, sample size, or outcome measures are described.
Approval date is in the future (2026), which may indicate a pre-approval summary or provisional status.

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 outcomes or comparative effectiveness data.

Consistency

insufficient

No trial results or comparative data provided in regulatory record.

Risk of bias

insufficient

Risk of bias assessment not applicable to regulatory approval action.

Sample adequacy

insufficient

No clinical sample or trial population described in this regulatory record.

Source abstract

Drugs@FDA record for application ANDA204166. This is a regulatory action record, not a clinical study. Brand name: METHADONE HYDROCHLORIDE. Active ingredient: METHADONE. Sponsor: VISTAPHARM LLC. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-06-18. Products: METHADONE HYDROCHLORIDE, TABLET, ORAL, METHADONE HYDROCHLORIDE 10MG.

Follow from this

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

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