Aspirin · Regulatory label update

FDA supplemental approval: Oxycodone AND Aspirin (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 a regulatory approval record documenting FDA supplemental approval of an oxycodone and aspirin combination tablet (ASPIRIN 325 mg + OXYCODONE HYDROCHLORIDE 4.8355 mg) from Actavis Labs FL Inc., with a Risk Evaluation and Mitigation Strategy (REMS) requirement. The record does not contain clinical trial results, efficacy data, or comparative evidence.

What was studied

Regulatory label update.

Key findings

Supplemental approval granted June 18, 2026 for OXYCODONE AND ASPIRIN combination tablet Formulation: ASPIRIN 325 mg + OXYCODONE HYDROCHLORIDE 4.8355 mg, oral tablet REMS (Risk Evaluation and Mitigation Strategy) designation applied

Safety

This is a regulatory action record and does not contain clinical trial results, efficacy data, safety outcomes, or comparative evidence.

Who this may help

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

Plain-language summary

FDA supplemental approval action for oxycodone and aspirin combination tablet with REMS requirement; does not report clinical trial outcomes or comparative efficacy.

Reported figures

Quoted from the source exactly as published.

Approval date2026-06-18

Aspirin dose325 mg

Oxycodone hydrochloride dose4.8355 mg

Caveats

This is a regulatory action record and does not contain clinical trial results, efficacy data, safety outcomes, or comparative evidence.
REMS designation indicates the FDA required a risk mitigation strategy, but specific REMS requirements are not detailed in this record.
No information on indication, dosing recommendations, or patient population is provided.
Approval status does not imply clinical superiority or comparative benefit over other products.

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

Record does not report clinical endpoints or patient outcomes.

Consistency

insufficient

No comparative data or replicate studies presented in record.

Risk of bias

insufficient

Regulatory approval record does not assess trial quality or bias.

Sample adequacy

insufficient

No sample size, trial population, or clinical data reported.

Source abstract

Drugs@FDA record for application ANDA090084. This is a regulatory action record, not a clinical study. Brand name: OXYCODONE AND ASPIRIN. Active ingredient: ASPIRIN. Sponsor: ACTAVIS LABS FL INC. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-06-18. Products: OXYCODONE AND ASPIRIN, TABLET, ORAL, ASPIRIN 325MG + OXYCODONE HYDROCHLORIDE 4.8355MG.

Follow from this

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

Actavis Labs FLAspirin