Methadone Hydrochloride · Regulatory label update

FDA supplemental approval: Methadone Hydrochloride (REMS)

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

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AI Summary

This is a supplemental FDA regulatory approval for methadone hydrochloride REMS (Risk Evaluation and Mitigation Strategy) submitted by Epic Pharma LLC for 5 mg and 10 mg oral tablets, approved on 18 June 2026. The record documents a regulatory action establishing risk management conditions but does not contain clinical trial results, efficacy data, or comparative effectiveness information.

What was studied

Regulatory label update.

Key findings

REMS supplement approved for methadone hydrochloride 5 mg and 10 mg oral tablets Approval date: 2026-06-18 Sponsor: Epic Pharma LLC

Safety

Record does not contain clinical trial results, efficacy data, or safety outcomes Approval of REMS does not constitute new evidence of clinical benefit or harm

Who this may help

This regulatory approval establishes REMS requirements for methadone hydrochloride dispensing and use; clinicians should consult the approved REMS program documentation for prescribing, dispensing, and monitoring obligations. This record does not evaluate or compare clinical efficacy.

Plain-language summary

FDA supplemental approval of methadone hydrochloride REMS establishes risk management requirements; does not report clinical trial efficacy or comparative outcomes.

Reported figures

Quoted from the source exactly as published.

Approval status date2026-06-18

Product strengths approved5 mg, 10 mg oral tablets

Clinical bottom line

Caveats

Record does not contain clinical trial results, efficacy data, or safety outcomes
No population studied, sample size, or control group reported
REMS requirements themselves are not detailed in this regulatory filing summary
Approval of REMS does not constitute new evidence of clinical benefit or harm

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 action record; no clinical study design present.

Directness

insufficient

Regulatory approval; not structured to address clinical efficacy questions.

Consistency

insufficient

Single regulatory action; no comparative evidence reported.

Risk of bias

insufficient

Regulatory record does not contain trial methodology or bias assessment.

Sample adequacy

insufficient

No study population or sample size reported in regulatory filing.

Source abstract

Drugs@FDA record for application ANDA090065. This is a regulatory action record, not a clinical study. Brand name: METHADONE HYDROCHLORIDE. Active ingredient: METHADONE HYDROCHLORIDE. Sponsor: EPIC PHARMA LLC. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-06-18. Products: METHADONE HYDROCHLORIDE, TABLET, ORAL, METHADONE HYDROCHLORIDE 10MG; METHADONE HYDROCHLORIDE, TABLET, ORAL, METHADONE HYDROCHLORIDE 5MG.

Follow from this

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

Epic PharmaMethadone Hydrochloride