Hydromorphone Hydrochloride · Regulatory label update

FDA supplemental approval: Hydromorphone 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

This is an FDA supplemental approval action granting REMS designation to extended-release hydromorphone hydrochloride tablets (8 mg, 12 mg, 16 mg, and 24 mg) by Osmotica Pharmaceuticals. The record documents regulatory authorization of risk management measures but does not contain clinical trial results, efficacy data, or safety outcomes.

What was studied

Regulatory label update.

Key findings

Approval granted for REMS supplement to ANDA205629 on 18 June 2026 Four extended-release tablet strengths approved: 8 mg, 12 mg, 16 mg, and 24 mg hydromorphone hydrochloride

Safety

This record does not contain clinical trial results, efficacy data, or comparative safety outcomes

Who this may help

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

Plain-language summary

FDA supplemental approval of a REMS (Risk Evaluation and Mitigation Strategy) for extended-release hydromorphone hydrochloride tablets; this is a regulatory action establishing risk management requirements, not a clinical efficacy or safety study.

Reported figures

Quoted from the source exactly as published.

Approval date2026-06-18

ANDA number205629

Tablet strengths approved8 mg, 12 mg, 16 mg, 24 mg

Caveats

This record does not contain clinical trial results, efficacy data, or comparative safety outcomes
REMS approval indicates risk management requirements; details of specific requirements are not provided in this record
No information on patient population, indication, or clinical outcomes is available
Approval status does not imply efficacy or clinical superiority over comparators

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

This is a regulatory approval record, not a clinical study.

Directness

insufficient

Regulatory action does not report clinical trial outcomes or comparative evidence.

Consistency

insufficient

Single regulatory action; consistency cannot be assessed from this record.

Risk of bias

insufficient

Risk of bias framework does not apply to regulatory approval records.

Sample adequacy

insufficient

No clinical trial population or sample size reported in regulatory record.

Source abstract

Drugs@FDA record for application ANDA205629. This is a regulatory action record, not a clinical study. Brand name: HYDROMORPHONE HYDROCHLORIDE. Active ingredient: HYDROMORPHONE HYDROCHLORIDE. Sponsor: OSMOTICA PHARM US. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-06-18. Products: HYDROMORPHONE HYDROCHLORIDE, TABLET, EXTENDED RELEASE, ORAL, HYDROMORPHONE HYDROCHLORIDE 12MG; HYDROMORPHONE HYDROCHLORIDE, TABLET, EXTENDED RELEASE, ORAL, HYDROMORPHONE HYDROCHLORIDE 24MG; HYDROMORPHONE HYDROCHLORIDE, TABLET, EXTENDED RELEASE, ORAL, HYDROMORPHONE HYDROCHLORIDE 16MG; HYDROMORPHONE HYDROCHLORIDE, TABLET, EXTENDED RELEASE, ORAL, HYDROMORPHONE HYDROCHLORIDE 8MG.

Follow from this

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

Osmotica Pharm USHydromorphone Hydrochloride