Tramadol Hydrochloride · Regulatory label update

FDA supplemental approval: Tramadol Hydrochloride (REMS)

U.S. Food and Drug Administration · June 18, 2026

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AI Summary

The FDA approved a supplemental application for tramadol hydrochloride 50 mg tablets under a Risk Evaluation and Mitigation Strategy (REMS) framework on 18 June 2026. This regulatory action mandates risk mitigation requirements for the product but does not evaluate or report clinical efficacy, comparative effectiveness, or trial outcomes.

What was studied

Regulatory label update.

Key findings

Approval classification: REMS supplement for tramadol hydrochloride 50 mg oral tablet Sponsor: CSPC Ouyi Pharmaceutical Co. Approval date: 18 June 2026

Safety

Regulatory record contains no clinical trial results, efficacy data, or safety endpoint comparisons. REMS approval does not imply superior efficacy or safety relative to other opioid formulations.

Who this may help

This approval establishes the regulatory pathway and risk mitigation requirements for this formulation but does not provide clinical evidence on efficacy, safety outcomes, or comparative benefit. Clinicians should refer to the approved REMS protocol and product labelling for prescribing obligations and patient safety monitoring requirements.

Plain-language summary

FDA supplemental approval of tramadol hydrochloride tablet formulation under REMS framework; establishes risk mitigation requirements but does not report clinical efficacy or comparative trial outcomes.

Reported figures

Quoted from the source exactly as published.

Dosage formTablet, oral, 50 mg

Approval date2026-06-18

Clinical bottom line

Caveats

Regulatory record contains no clinical trial results, efficacy data, or safety endpoint comparisons.
REMS approval does not imply superior efficacy or safety relative to other opioid formulations.
Source does not report trial sample size, study duration, primary endpoints, or adverse event rates.
Specific REMS requirements and implementation details are not described in this record.

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 present.

Directness

insufficient

REMS approval does not directly address clinical efficacy or comparative benefit.

Consistency

insufficient

Single regulatory action; no comparative or confirmatory data reported.

Risk of bias

insufficient

Regulatory document; clinical trial bias assessment not applicable.

Sample adequacy

insufficient

No trial population or sample size; regulatory approval does not report trial data.

Source abstract

Drugs@FDA record for application ANDA091498. This is a regulatory action record, not a clinical study. Brand name: TRAMADOL HYDROCHLORIDE. Active ingredient: TRAMADOL HYDROCHLORIDE. Sponsor: CSPC OUYI PHARM CO. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-06-18. Products: TRAMADOL HYDROCHLORIDE, TABLET, ORAL, TRAMADOL HYDROCHLORIDE 50MG.

Follow from this

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

Tramadol HydrochlorideCspc Ouyi Pharm