Oxycodone Hydrochloride · Regulatory label update

FDA supplemental approval: Roxybond (REMS)

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

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AI Summary

The FDA approved a supplemental REMS (Risk Evaluation and Mitigation Strategy) application for Roxybond (oxycodone hydrochloride) on 18 June 2026. This is a regulatory action record documenting approval of risk management requirements, not a report of clinical efficacy or safety trial outcomes.

What was studied

Regulatory label update.

Key findings

Supplemental REMS approval granted for Roxybond (oxycodone hydrochloride tablets: 5 mg, 10 mg, 15 mg, 30 mg oral formulations) Approval date: 2026-06-18

Safety

This record contains no clinical trial data, efficacy outcomes, safety data, or comparative effectiveness information.

Who this may help

This regulatory record documents FDA approval of REMS requirements for Roxybond but does not report clinical trial results, efficacy data, or safety comparisons. Clinicians should consult the approved labeling and REMS programme details for prescribing guidance and risk mitigation requirements.

Plain-language summary

FDA supplemental approval of REMS requirements for Roxybond (oxycodone hydrochloride); this is a regulatory action record without clinical trial data.

Reported figures

Quoted from the source exactly as published.

Approval status date2026-06-18

Clinical bottom line

Caveats

This record contains no clinical trial data, efficacy outcomes, safety data, or comparative effectiveness information.
The nature and scope of the REMS requirements are not detailed in this record.
No information on patient population, indications, or clinical evidence supporting the approval is provided.

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.

Directness

insufficient

Record documents approval action only; no clinical outcomes reported.

Consistency

insufficient

Single regulatory action; no comparative data provided.

Risk of bias

insufficient

Not applicable to regulatory approval documentation.

Sample adequacy

insufficient

No clinical trial population or sample size reported.

Source abstract

Drugs@FDA record for application NDA209777. This is a regulatory action record, not a clinical study. Brand name: ROXYBOND. Active ingredient: OXYCODONE HYDROCHLORIDE. Sponsor: PROTEGA PHARMS. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-06-18. Products: ROXYBOND, TABLET, ORAL, OXYCODONE HYDROCHLORIDE 10MG; ROXYBOND, TABLET, ORAL, OXYCODONE HYDROCHLORIDE 15MG; ROXYBOND, TABLET, ORAL, OXYCODONE HYDROCHLORIDE 30MG; ROXYBOND, TABLET, ORAL, OXYCODONE HYDROCHLORIDE 5MG.

Follow from this

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

Oxycodone HydrochlorideProtega Pharms