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 FDA supplemental approval (REMS) for methadone hydrochloride tablets (5 mg and 10 mg formulations) by SUN PHARM INDUSTRIES, approved 18 June 2026. The record documents a regulatory action only and does not contain clinical trial results, efficacy data, or comparative evidence.

What was studied

Regulatory label update.

Key findings

Supplemental REMS approval granted for methadone hydrochloride tablet formulations (5 mg and 10 mg oral tablets) Sponsor: SUN PHARM INDUSTRIES; Application number ANDA208305

Safety

This record does not contain clinical trial results, efficacy data, safety outcomes, or comparative effectiveness evidence Sponsor: SUN PHARM INDUSTRIES; Application number ANDA208305

Who this may help

This approval affects the availability of methadone formulations under REMS requirements. Clinicians should reference the complete REMS program requirements from the FDA for appropriate prescribing, dispensing, and monitoring protocols.

Plain-language summary

FDA supplemental approval action for methadone hydrochloride REMS; regulatory classification, not efficacy evidence.

Reported figures

Quoted from the source exactly as published.

Approval date2026-06-18

Dosage strengths approved5 mg, 10 mg oral tablets

Clinical bottom line

Caveats

This record does not contain clinical trial results, efficacy data, safety outcomes, or comparative effectiveness evidence
No information provided on the specific REMS requirements or risk mitigation strategies
No population characteristics, sample size, or clinical endpoints reported
Approval status does not imply efficacy demonstration; REMS approval is a regulatory classification related to risk management

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 reported.

Directness

insufficient

REMS approval document does not report clinical outcomes or trial data.

Consistency

insufficient

No comparative or replication data provided in this approval record.

Risk of bias

insufficient

Regulatory action; no trial methodology or bias assessment applicable.

Sample adequacy

insufficient

No patient population or sample size reported in approval record.

Source abstract

Drugs@FDA record for application ANDA208305. This is a regulatory action record, not a clinical study. Brand name: METHADONE HYDROCHLORIDE. Active ingredient: METHADONE HYDROCHLORIDE. Sponsor: SUN PHARM INDUSTRIES. 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.

Methadone HydrochlorideSUN Pharm Industries