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

The FDA approved a supplemental REMS application for oxycodone and acetaminophen combination tablets (5 mg and 10 mg oxycodone formulations) sponsored by Lannett Co Inc, effective 18 June 2026. This is a regulatory action pertaining to risk mitigation requirements, not a report of clinical trial results or safety data.

What was studied

Regulatory label update.

Key findings

Supplemental REMS approval granted for oxycodone 5 mg + acetaminophen 325 mg tablets Supplemental REMS approval granted for oxycodone 10 mg + acetaminophen 325 mg tablets Approval date: 18 June 2026

Safety

This is a regulatory action record, not a clinical trial or safety study; no efficacy, comparative benefit, or adverse event data are reported. No safety or efficacy trial results are included in this regulatory approval notice.

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 an existing oxycodone–acetaminophen combination, representing a regulatory action rather than new clinical evidence of efficacy or safety.

Reported figures

Quoted from the source exactly as published.

Oxycodone dose (formulation 1)5 mg

Acetaminophen dose (formulation 1)325 mg

Oxycodone dose (formulation 2)10 mg

Acetaminophen dose (formulation 2)325 mg

Approval date2026-06-18

Caveats

This is a regulatory action record, not a clinical trial or safety study; no efficacy, comparative benefit, or adverse event data are reported.
The record does not specify what REMS requirements were approved, modified, or why.
No information on patient populations affected or clinical indications is provided.
No safety or efficacy trial results are included in this regulatory approval notice.

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 present.

Directness

insufficient

Record documents approval action; no clinical outcome data reported.

Consistency

insufficient

No comparative or outcome data provided in this record.

Risk of bias

insufficient

Regulatory approval record; bias assessment not applicable.

Sample adequacy

insufficient

No patient population or sample size in regulatory action record.

Source abstract

Drugs@FDA record for application ANDA207333. This is a regulatory action record, not a clinical study. Brand name: OXYCODONE AND ACETAMINOPHEN. Active ingredient: ACETAMINOPHEN. Sponsor: LANNETT CO INC. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-06-18. Products: OXYCODONE AND ACETAMINOPHEN, TABLET, ORAL, ACETAMINOPHEN 325MG + OXYCODONE HYDROCHLORIDE 5MG; OXYCODONE AND ACETAMINOPHEN, TABLET, ORAL, ACETAMINOPHEN 325MG + OXYCODONE HYDROCHLORIDE 10MG.

Follow from this

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

Lannett COAcetaminophen