Oxymorphone Hydrochloride · Regulatory label update

FDA supplemental approval: Oxymorphone Hydrochloride (REMS)

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

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AI Summary

The FDA approved a supplemental Risk Evaluation and Mitigation Strategy (REMS) for oxymorphone hydrochloride tablets (5 mg and 10 mg oral formulations) under sponsor HIKMA on 18 June 2026. This is a regulatory action specifying risk management requirements; it does not report clinical trial data, efficacy, safety outcomes, or comparative benefit.

What was studied

Regulatory label update.

Key findings

Safety

This record does not contain clinical trial results, efficacy data, or safety outcomes.

Who this may help

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

Plain-language summary

FDA supplemental approval of REMS for oxymorphone hydrochloride; regulatory action only, not a clinical trial or efficacy study.

Reported figures

Quoted from the source exactly as published.

Approval date2026-06-18

Dosage strengths approved5 mg and 10 mg tablets, oral

Caveats

This record does not contain clinical trial results, efficacy data, or safety outcomes.
REMS approval is a regulatory risk-mitigation action; no comparative data or control arm is reported.
No information on patient population, indication, or clinical rationale for the REMS is provided in this record.
Specific requirements of the REMS programme are not detailed in this source.

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 record; no study design applicable.

Directness

insufficient

No clinical outcomes reported; regulatory action only.

Consistency

insufficient

Single regulatory action; consistency cannot be assessed.

Risk of bias

insufficient

Not a clinical study; bias assessment not applicable.

Sample adequacy

insufficient

No patient population or sample size in record.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Drugs@FDA record for application ANDA090964. This is a regulatory action record, not a clinical study. Brand name: OXYMORPHONE HYDROCHLORIDE. Active ingredient: OXYMORPHONE HYDROCHLORIDE. Sponsor: HIKMA. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-06-18. Products: OXYMORPHONE HYDROCHLORIDE, TABLET, ORAL, OXYMORPHONE HYDROCHLORIDE 10MG; OXYMORPHONE HYDROCHLORIDE, TABLET, ORAL, OXYMORPHONE HYDROCHLORIDE 5MG.

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Oxymorphone HydrochlorideHikma