Oxycodone Hydrochloride · Regulatory label update

FDA supplemental approval: Oxycodone Hydrochloride (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 ANDS application for oxycodone hydrochloride 5 mg capsules (oral) under REMS on 18 June 2026. This is a regulatory action permitting marketing of the formulation subject to Risk Evaluation and Mitigation Strategy requirements; it does not report clinical efficacy, safety outcomes, or comparative benefit data.

What was studied

Regulatory label update.

Key findings

Supplemental ANDS approval granted for oxycodone hydrochloride 5 mg oral capsule formulation

Safety

This record documents regulatory approval only and does not contain clinical trial results, efficacy data, safety outcomes, or comparative effectiveness information.

Who this may help

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

Plain-language summary

FDA supplemental approval of an oxycodone hydrochloride formulation under REMS; a regulatory action that does not itself report clinical trial outcomes or comparative efficacy.

Reported figures

Quoted from the source exactly as published.

Approval status date2026-06-18

Caveats

This record documents regulatory approval only and does not contain clinical trial results, efficacy data, safety outcomes, or comparative effectiveness information.
REMS status indicates risk mitigation requirements apply; specific requirements are not detailed in this record.
No sample size, endpoints, or trial methodology reported.

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 approval record; no clinical study design reported.

Directness

insufficient

Record documents regulatory action only, not clinical outcomes.

Consistency

insufficient

Single regulatory action; no comparative data provided.

Risk of bias

insufficient

Not applicable to a regulatory approval record.

Sample adequacy

insufficient

No clinical trial sample size or population data reported.

Source abstract

Drugs@FDA record for application ANDA204752. This is a regulatory action record, not a clinical study. Brand name: OXYCODONE HYDROCHLORIDE. Active ingredient: OXYCODONE HYDROCHLORIDE. Sponsor: NOVEL LABS INC. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-06-18. Products: OXYCODONE HYDROCHLORIDE, CAPSULE, 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.

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