Oxycodone AND Acetaminophen · Regulatory label update

FDA supplemental approval: Oxycodone AND Acetaminophen (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 supplemental approval granting a Risk Evaluation and Mitigation Strategy (REMS) classification for oxycodone/acetaminophen combination tablets in four strengths (2.5 mg, 5 mg, 7.5 mg, and 10 mg oxycodone with 325 mg acetaminophen) by Ascent Pharms Inc., approved 18 June 2026. The document is a regulatory action record and does not contain clinical trial results, efficacy data, or safety comparisons.

What was studied

Regulatory label update. Intervention: Oxycodone hydrochloride 2.5 mg, 5 mg, 7.5 mg, or 10 mg combined with acetaminophen 325 mg in tablet form, oral administration.

Key findings

Safety

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

Who this may help

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

Plain-language summary

FDA supplemental approval of a REMS submission for existing oxycodone/acetaminophen combination tablets; this is a regulatory action, not a clinical trial, and does not report efficacy or safety data.

Study design

As stated by the source record.

InterventionOxycodone hydrochloride 2.5 mg, 5 mg, 7.5 mg, or 10 mg combined with acetaminophen 325 mg in tablet form, oral administration

Reported figures

Quoted from the source exactly as published.

Approval status date2026-06-18

Oxycodone strength 12.5 mg

Oxycodone strength 25 mg

Oxycodone strength 37.5 mg

Oxycodone strength 410 mg

Acetaminophen strength325 mg

Caveats

This record does not contain clinical trial results, efficacy data, or comparative safety information.
REMS approval indicates risk mitigation measures required; specific restrictions and monitoring requirements are not detailed in this summary.
No patient population, sample size, or outcome measures are reported.
The approval date (2026-06-18) is a future date and may reflect data currency or record publication timing rather than current approval status.

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; no clinical study design reported.

Directness

insufficient

Approval document does not contain clinical outcome data.

Consistency

insufficient

No comparative or historical trial data provided in record.

Risk of bias

insufficient

Regulatory action; clinical trial methodology not assessed in this document.

Sample adequacy

insufficient

No patient population or sample size reported in approval 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 ANDA207419. This is a regulatory action record, not a clinical study. Brand name: OXYCODONE AND ACETAMINOPHEN. Active ingredient: OXYCODONE AND ACETAMINOPHEN. Sponsor: ASCENT PHARMS INC. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-06-18. Products: OXYCODONE AND ACETAMINOPHEN, TABLET, ORAL, ACETAMINOPHEN 325MG + OXYCODONE HYDROCHLORIDE 10MG; OXYCODONE AND ACETAMINOPHEN, TABLET, ORAL, ACETAMINOPHEN 325MG + OXYCODONE HYDROCHLORIDE 5MG; OXYCODONE AND ACETAMINOPHEN, TABLET, ORAL, ACETAMINOPHEN 325MG + OXYCODONE HYDROCHLORIDE 7.5MG; OXYCODONE AND ACETAMINOPHEN, TABLET, ORAL, ACETAMINOPHEN 325MG + OXYCODONE HYDROCHLORIDE 2.5MG.

Follow from this

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

Ascent PharmsOxycodone AND Acetaminophen