FDA supplemental approval: Hydrocodone Bitartrate AND Acetaminophen (REMS)

AI Summary

This record documents FDA approval of a supplemental REMS (Risk Evaluation and Mitigation Strategy) application for hydrocodone bitartrate and acetaminophen combination tablets in four dosage strengths (2.5 mg, 5 mg, 7.5 mg, and 10 mg hydrocodone with 325 mg acetaminophen), submitted by Alvogen and approved on 2026-06-18. The regulatory action does not include clinical efficacy or safety trial results; it confirms implementation of required risk mitigation measures for this opioid-containing product.

Plain-language summary

FDA supplemental approval of a Risk Evaluation and Mitigation Strategy (REMS) for hydrocodone bitartrate and acetaminophen combination tablets across four dosage strengths.

Reported figures

Quoted from the source exactly as published.

Caveats

• This is a regulatory approval record, not a clinical study; no efficacy, safety, or comparative trial data are reported.
• The record confirms REMS approval but does not provide the specific requirements or content of the REMS itself.
• No clinical outcomes, adverse event rates, or comparative effectiveness data are included in this record.
• The approval indicates only that regulatory conditions for this product formulation have been met; it does not report clinical trial results.

Evidence assessment

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