Hydromorphone Hydrochloride · Regulatory label update

FDA supplemental approval: Dilaudid (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 Dilaudid (hydromorphone hydrochloride) oral tablets on 18 June 2026. This is a regulatory compliance action and does not report clinical trial results, efficacy data, or safety outcomes; it addresses risk mitigation requirements for an existing opioid product.

What was studied

Regulatory label update.

Key findings

FDA supplemental REMS approval for Dilaudid oral tablets (2 mg, 4 mg, 8 mg strengths) effective 18 June 2026

Safety

This record contains no clinical trial results, efficacy data, safety outcomes, or comparative effectiveness information. The approval status reflects regulatory compliance with REMS requirements only; it does not imply new evidence of clinical benefit or safety profile.

Who this may help

This regulatory action does not provide clinical efficacy or safety evidence and should not be used to guide treatment decisions. Healthcare professionals should refer to the approved REMS program requirements and the full prescribing information for Dilaudid for relevant safety and risk mitigation guidance.

Plain-language summary

FDA supplemental approval of a Risk Evaluation and Mitigation Strategy (REMS) for hydromorphone; this is a regulatory action, not a clinical trial, and does not report efficacy or safety trial outcomes.

Reported figures

Quoted from the source exactly as published.

Approval date2026-06-18

Product strengths approved2 mg, 4 mg, 8 mg oral tablets

Clinical bottom line

Caveats

This record contains no clinical trial results, efficacy data, safety outcomes, or comparative effectiveness information.
The record does not specify what REMS changes or updates were approved in this supplement.
No population, sample size, or study methodology is reported.
The approval status reflects regulatory compliance with REMS requirements only; it does not imply new evidence of clinical benefit or safety profile.

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 contain clinical trial data or efficacy endpoints.

Consistency

insufficient

Single regulatory action; no comparative or replication data provided.

Risk of bias

insufficient

Regulatory approval record; trial methodology and bias assessment not reported.

Sample adequacy

insufficient

No clinical sample size, population, or trial data reported in this record.

Source abstract

Drugs@FDA record for application NDA019892. This is a regulatory action record, not a clinical study. Brand name: DILAUDID. Active ingredient: HYDROMORPHONE HYDROCHLORIDE. Sponsor: RHODES PHARMS. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-06-18. Products: DILAUDID, TABLET, ORAL, HYDROMORPHONE HYDROCHLORIDE 2MG; DILAUDID, TABLET, ORAL, HYDROMORPHONE HYDROCHLORIDE 8MG; DILAUDID, TABLET, ORAL, HYDROMORPHONE HYDROCHLORIDE 4MG.

Follow from this

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

Rhodes PharmsHydromorphone Hydrochloride