Hydrocodone Bitartrate AND Acetaminophen · Regulatory label update

FDA supplemental approval: Hydrocodone Bitartrate AND Acetaminophen (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 application (REMS) for hydrocodone bitartrate 7.5 mg + acetaminophen 325 mg tablets (ANEXSIA) on 18 June 2026, sponsored by SpecGX LLC. This is a regulatory action document that does not contain clinical trial results, efficacy data, or comparative safety evidence.

What was studied

Regulatory label update.

Key findings

REMS supplemental approval granted for ANEXSIA 7.5/325 (hydrocodone bitartrate 7.5 mg + acetaminophen 325 mg oral tablets) Approval date: 18 June 2026 Sponsor: SpecGX LLC

Safety

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

Who this may help

This regulatory record documents FDA approval of a REMS supplement for an existing opioid–analgesic combination. Clinicians should consult the full REMS requirements and product labeling for restrictions on prescribing, dispensing, and monitoring; this record does not convey clinical efficacy or comparative safety data.

Plain-language summary

FDA supplemental approval action for a Risk Evaluation and Mitigation Strategy (REMS) governing an existing hydrocodone–acetaminophen combination product; regulatory actions do not report clinical efficacy or trial outcomes.

Reported figures

Quoted from the source exactly as published.

Product strengthHydrocodone bitartrate 7.5 mg + Acetaminophen 325 mg

Approval date2026-06-18

Clinical bottom line

Caveats

This record does not contain clinical trial results, efficacy endpoints, or safety comparative data.
No sample size, population demographics, or study duration are reported.
The full REMS terms and conditions are not described in this summary.
No information is provided on why this supplemental approval was requested or what changes were made to the existing REMS.

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, not a clinical study or trial.

Directness

insufficient

Regulatory record does not report clinical endpoints or comparative outcomes.

Consistency

insufficient

Record does not compare results across populations or settings.

Risk of bias

insufficient

Risk of bias assessment does not apply to regulatory approval actions.

Sample adequacy

insufficient

Regulatory record contains no sample size or trial population data.

Source abstract

Drugs@FDA record for application ANDA040405. This is a regulatory action record, not a clinical study. Brand name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN. Active ingredient: HYDROCODONE BITARTRATE AND ACETAMINOPHEN. Sponsor: SPECGX LLC. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-06-18. Products: ANEXSIA 7.5/325, TABLET, ORAL, ACETAMINOPHEN 325MG + HYDROCODONE BITARTRATE 7.5MG.

Follow from this

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

SpecgxHydrocodone Bitartrate AND Acetaminophen