Hydrocodone Bitartrate · Regulatory label update

FDA supplemental approval: Hydrocodone Bitartrate (REMS)

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

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AI Summary

The FDA approved a supplemental REMS application for Alvogen's extended-release hydrocodone bitartrate tablets (20 mg, 40 mg, 80 mg, and 120 mg formulations) on June 18, 2026. This is a regulatory action addressing risk mitigation requirements; it does not contain clinical trial efficacy or safety outcome data.

What was studied

Regulatory label update.

Key findings

Supplemental REMS approval granted for extended-release hydrocodone bitartrate by the FDA on 2026-06-18 Four tablet strengths approved: 20 mg, 40 mg, 80 mg, and 120 mg oral extended-release formulations

Safety

This is a regulatory approval record, not a clinical trial; no efficacy, safety outcomes, or comparative data are reported.

Who this may help

This record documents regulatory approval of a REMS requirement for extended-release hydrocodone; clinicians should consult the approved REMS labelling and risk minimization requirements. This approval does not convey information about efficacy, safety profile, or comparative clinical benefit versus other opioids.

Plain-language summary

FDA supplemental approval of a Risk Evaluation and Mitigation Strategy (REMS) for extended-release hydrocodone bitartrate; this is a regulatory action, not a clinical efficacy study.

Reported figures

Quoted from the source exactly as published.

Approval date2026-06-18

Formulations approved20 mg, 40 mg, 80 mg, 120 mg extended-release tablets

Clinical bottom line

Caveats

This is a regulatory approval record, not a clinical trial; no efficacy, safety outcomes, or comparative data are reported.
The specific content and requirements of the approved REMS are not detailed in this record.
No information on population studied, sample size, or clinical endpoints.
Approval does not indicate new efficacy data; REMS supplements typically address risk mitigation rather than new clinical evidence.

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 action record, not a clinical trial.

Directness

insufficient

Record does not report clinical outcomes or efficacy data.

Consistency

insufficient

No comparative or outcome data provided in this regulatory record.

Risk of bias

insufficient

Regulatory approval does not undergo trial-level bias assessment.

Sample adequacy

insufficient

This is a regulatory labelling/REMS action, not a study with a sample.

Source abstract

Drugs@FDA record for application ANDA208269. This is a regulatory action record, not a clinical study. Brand name: HYDROCODONE BITARTRATE. Active ingredient: HYDROCODONE BITARTRATE. Sponsor: ALVOGEN. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-06-18. Products: HYDROCODONE BITARTRATE, TABLET, EXTENDED RELEASE, ORAL, HYDROCODONE BITARTRATE 120MG; HYDROCODONE BITARTRATE, TABLET, EXTENDED RELEASE, ORAL, HYDROCODONE BITARTRATE 80MG; HYDROCODONE BITARTRATE, TABLET, EXTENDED RELEASE, ORAL, HYDROCODONE BITARTRATE 40MG; HYDROCODONE BITARTRATE, TABLET, EXTENDED RELEASE, ORAL, HYDROCODONE BITARTRATE 20MG.

Follow from this

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

AlvogenHydrocodone Bitartrate