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

The FDA approved a supplemental application for a Risk Evaluation and Mitigation Strategy (REMS) for oxymorphone hydrochloride extended-release tablets (10, 15, 30, and 40 mg) on 18 June 2026. This is a regulatory authorization action and does not report clinical trial data, efficacy outcomes, or safety results; it reflects the sponsor's submission of risk management procedures required for this controlled opioid product.

What was studied

Regulatory label update.

Key findings

REMS supplement approved for oxymorphone hydrochloride extended-release tablets in four strengths: 10 mg, 15 mg, 30 mg, and 40 mg

Safety

This record does not contain clinical trial results, efficacy data, or safety outcome measures. Approval of a REMS supplement does not itself imply new clinical evidence or changes to product safety or efficacy labelling.

Who this may help

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

Plain-language summary

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

Reported figures

Quoted from the source exactly as published.

Approval date2026-06-18

Product strengths approved10 mg, 15 mg, 30 mg, 40 mg

Caveats

This record does not contain clinical trial results, efficacy data, or safety outcome measures.
The specific requirements and components of the approved REMS are not detailed in this regulatory action summary.
Approval of a REMS supplement does not itself imply new clinical evidence or changes to product safety or efficacy labelling.
No information is provided on the indication, dosing guidance, or patient population for which the REMS applies.

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 with a defined design.

Directness

insufficient

Record does not report clinical trial outcomes or direct patient-relevant data.

Consistency

insufficient

No comparative or replication data provided in this regulatory record.

Risk of bias

insufficient

Regulatory approval mechanism does not involve trial bias assessment.

Sample adequacy

insufficient

This is not a trial; no patient sample is described or analysed here.

Source abstract

Drugs@FDA record for application ANDA079046. This is a regulatory action record, not a clinical study. Brand name: OXYMORPHONE HYDROCHLORIDE. Active ingredient: OXYMORPHONE HYDROCHLORIDE. Sponsor: ACTAVIS ELIZABETH. 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 10MG; OXYMORPHONE HYDROCHLORIDE, TABLET, EXTENDED RELEASE, ORAL, OXYMORPHONE HYDROCHLORIDE 15MG; 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.

Actavis ElizabethOxymorphone Hydrochloride