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 a regulatory approval action by the FDA, not a clinical study. Ascent Pharma Inc. received supplemental approval (ANDA 211228) on 18 June 2026 for methadone hydrochloride tablets (5 mg and 10 mg formulations) under a Risk Evaluation and Mitigation Strategy (REMS). The record does not contain clinical trial results, efficacy data, or comparative outcomes.

What was studied

Regulatory label update.

Key findings

Supplemental ANDA approval granted for methadone hydrochloride 5 mg and 10 mg oral tablets Approval action issued 18 June 2026 under REMS submission class

Safety

This record contains no clinical trial data, efficacy outcomes, or safety analyses Population characteristics, dosing studies, and pharmacokinetic data not included in this approval notice

Who this may help

This approval permits marketing of a new methadone formulation under REMS controls. Clinicians should refer to the approved REMS requirements for prescribing, dispensing, and patient monitoring obligations. The record does not assess clinical efficacy or superiority.

Plain-language summary

FDA supplemental approval of methadone hydrochloride under REMS, a regulatory action affecting drug access and safety monitoring requirements, not a clinical efficacy study.

Reported figures

Quoted from the source exactly as published.

Application numberANDA211228

Approval date2026-06-18

Formulations approvedMethadone hydrochloride 5 mg and 10 mg tablets, oral

Clinical bottom line

Caveats

This record contains no clinical trial data, efficacy outcomes, or safety analyses
REMS requirements themselves are not detailed in this record; consult the full REMS program documentation
No comparative data with other methadone formulations or alternative treatments reported
Population characteristics, dosing studies, and pharmacokinetic data not included in this approval notice

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

Regulatory approval record; no clinical trial design present.

Directness

insufficient

Record documents approval action only; does not report clinical outcomes.

Consistency

insufficient

No comparative or replication data reported in this record.

Risk of bias

insufficient

Regulatory approval does not include bias assessment or trial methodology.

Sample adequacy

insufficient

No clinical population or sample size data reported.

Source abstract

Drugs@FDA record for application ANDA211228. This is a regulatory action record, not a clinical study. Brand name: METHADONE HYDROCHLORIDE. Active ingredient: METHADONE HYDROCHLORIDE. Sponsor: ASCENT PHARMS INC. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-06-18. Products: METHADONE HYDROCHLORIDE, TABLET, ORAL, METHADONE HYDROCHLORIDE 5MG; 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.

Ascent PharmsMethadone Hydrochloride