Oxymorphone Hydrochloride · Regulatory label update

FDA supplemental approval: Oxymorphone 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 action granting FDA approval of a Risk Evaluation and Mitigation Strategy (REMS) supplement for oxymorphone hydrochloride extended-release tablets in four strengths (7.5, 15, 30, and 40 mg). The record documents a regulatory compliance decision and does not report clinical trial outcomes, efficacy data, or safety findings.

What was studied

Regulatory label update.

Key findings

REMS supplement approved for oxymorphone hydrochloride extended-release tablets on 2026-06-18 Four extended-release tablet strengths covered: 7.5 mg, 15 mg, 30 mg, 40 mg Sponsor: IMPAX LABS; Application ANDA079087

Safety

This record is a regulatory approval action only and does not contain clinical trial results, efficacy data, safety outcomes, or comparative effectiveness data.

Who this may help

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

Plain-language summary

FDA supplemental approval action for a Risk Evaluation and Mitigation Strategy (REMS) programme for oxymorphone hydrochloride extended-release tablets; this is a regulatory decision, not a clinical efficacy or safety study.

Reported figures

Quoted from the source exactly as published.

Approval status date2026-06-18

Submission typeSUPPL (supplement)

Submission classREMS

Tablet strengths approved7.5 mg, 15 mg, 30 mg, 40 mg

Caveats

This record is a regulatory approval action only and does not contain clinical trial results, efficacy data, safety outcomes, or comparative effectiveness data.
No information provided on the content, requirements, or implementation details of the approved REMS programme.
No patient population, sample size, or outcome metrics reported.

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 trial or study.

Directness

insufficient

No clinical outcomes or comparators reported in this regulatory record.

Consistency

insufficient

No comparative data or prior trials cited in this approval document.

Risk of bias

insufficient

Regulatory approval does not contain bias assessment; based on prior NDA review.

Sample adequacy

insufficient

No clinical sample or population studied in this REMS supplement approval.

Source abstract

Drugs@FDA record for application ANDA079087. This is a regulatory action record, not a clinical study. Brand name: OXYMORPHONE HYDROCHLORIDE. Active ingredient: OXYMORPHONE HYDROCHLORIDE. Sponsor: IMPAX LABS. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-06-18. Products: OXYMORPHONE HYDROCHLORIDE, TABLET, EXTENDED RELEASE, ORAL, OXYMORPHONE HYDROCHLORIDE 30MG; OXYMORPHONE HYDROCHLORIDE, TABLET, EXTENDED RELEASE, ORAL, OXYMORPHONE HYDROCHLORIDE 15MG; OXYMORPHONE HYDROCHLORIDE, TABLET, EXTENDED RELEASE, ORAL, OXYMORPHONE HYDROCHLORIDE 7.5MG; OXYMORPHONE HYDROCHLORIDE, TABLET, EXTENDED RELEASE, ORAL, OXYMORPHONE HYDROCHLORIDE 40MG.

Follow from this

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

Oxymorphone HydrochlorideImpax Labs