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

This is a supplemental FDA regulatory approval for oxymorphone hydrochloride tablets (5 mg and 10 mg) via ANDA 204459, submitted by AuroLife Pharma LLC, establishing a Risk Evaluation and Mitigation Strategy (REMS). The record documents approval status only and does not contain clinical trial results, efficacy data, or safety comparative evidence.

What was studied

Regulatory label update.

Key findings

Supplemental approval granted for oxymorphone hydrochloride tablets 5 mg and 10 mg oral formulations REMS (Risk Evaluation and Mitigation Strategy) submission class Approval status date: 2026-06-18

Safety

Record contains no clinical trial results, efficacy data, or comparative safety evidence. No information on underlying clinical or safety rationale for supplemental approval.

Who this may help

This regulatory record does not provide clinical evidence to guide prescribing. Clinicians should consult the approved product labeling and REMS requirements, which are designed to mitigate risks associated with oxymorphone hydrochloride use.

Plain-language summary

FDA supplemental approval for oxymorphone hydrochloride REMS; regulatory action establishing risk mitigation strategy, not clinical efficacy data.

Reported figures

Quoted from the source exactly as published.

Approval status date2026-06-18

Product strength 15 mg

Product strength 210 mg

Clinical bottom line

Caveats

Record contains no clinical trial results, efficacy data, or comparative safety evidence.
REMS requirements and specific risk mitigation measures are not detailed in this record.
No information on underlying clinical or safety rationale for supplemental approval.
Does not indicate whether approval represents new indication, formulation change, or manufacturing site/process update.

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 clinical study design applicable.

Directness

insufficient

Record does not report clinical outcomes or direct efficacy evidence.

Consistency

insufficient

Single regulatory action; no comparative data or consistency assessment.

Risk of bias

insufficient

Not a clinical trial; bias assessment not applicable to REMS approval.

Sample adequacy

insufficient

No study population or sample size reported in regulatory record.

Source abstract

Drugs@FDA record for application ANDA204459. This is a regulatory action record, not a clinical study. Brand name: OXYMORPHONE HYDROCHLORIDE. Active ingredient: OXYMORPHONE HYDROCHLORIDE. Sponsor: AUROLIFE PHARMA LLC. 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.

Follow from this

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

Oxymorphone HydrochlorideAurolife Pharma