Oxycodone Hydrochloride · Regulatory label update

FDA supplemental approval: Oxycontin (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 an FDA regulatory action approving a supplemental REMS submission for OxyContin (oxycodone hydrochloride extended-release tablets) across four dosages (10 mg, 20 mg, 30 mg, 60 mg) on 18 June 2026. The record documents an administrative approval but does not contain clinical trial results, efficacy data, safety outcomes, or details of the REMS program itself.

What was studied

Regulatory label update.

Key findings

FDA supplemental approval issued 2026-06-18 for OxyContin REMS

Safety

This record does not contain clinical trial results, efficacy data, safety studies, or outcome measures.

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 OxyContin; this is a regulatory action, not a clinical study, and does not report efficacy or comparative trial outcomes.

Reported figures

Quoted from the source exactly as published.

Approval date2026-06-18

Dosages approved10 mg, 20 mg, 30 mg, 60 mg extended-release oral tablets

Caveats

This record does not contain clinical trial results, efficacy data, safety studies, or outcome measures.
No details of the REMS program content, requirements, or rationale are provided in this regulatory record.
No comparative data, patient population size, or duration of approval are stated.
The approval action itself does not constitute evidence for clinical benefit or risk mitigation effectiveness.

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 action record; not a clinical study.

Directness

insufficient

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

Consistency

insufficient

No comparative data or outcome measures reported.

Risk of bias

insufficient

Regulatory approval does not include bias assessment.

Sample adequacy

insufficient

No patient population or sample size data in regulatory record.

Source abstract

Drugs@FDA record for application NDA022272. This is a regulatory action record, not a clinical study. Brand name: OXYCONTIN. Active ingredient: OXYCODONE HYDROCHLORIDE. Sponsor: KNOA PHARMA. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-06-18. Products: OXYCONTIN, TABLET, EXTENDED RELEASE, ORAL, OXYCODONE HYDROCHLORIDE 20MG; OXYCONTIN, TABLET, EXTENDED RELEASE, ORAL, OXYCODONE HYDROCHLORIDE 10MG; OXYCONTIN, TABLET, EXTENDED RELEASE, ORAL, OXYCODONE HYDROCHLORIDE 60MG; OXYCONTIN, TABLET, EXTENDED RELEASE, ORAL, OXYCODONE HYDROCHLORIDE 30MG.

Follow from this

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

Oxycodone HydrochlorideKnoa Pharma