FDA supplemental approval: Hydrocodone Bitartrate AND Acetaminophen (REMS)

AI Summary

The FDA granted supplemental approval on 18 June 2026 for REMS modifications to hydrocodone bitartrate and acetaminophen oral solutions at two strengths (acetaminophen 325 mg/15 mL with hydrocodone 7.5 mg/15 mL, and acetaminophen 300 mg/15 mL with hydrocodone 10 mg/15 mL) manufactured by Tris Pharma Inc. This is a regulatory action establishing risk management requirements; it does not contain clinical trial results, efficacy data, or comparative benefit evidence.

Plain-language summary

FDA supplemental approval of a REMS (Risk Evaluation and Mitigation Strategy) for an existing hydrocodone bitartrate and acetaminophen oral solution; this is a regulatory action, not a clinical trial, and does not report efficacy or comparative benefit data.

Reported figures

Quoted from the source exactly as published.

Clinical bottom line

This regulatory action establishes REMS requirements for the named oral solution products. Healthcare professionals and patients must comply with the applicable risk mitigation strategy; clinicians should review current REMS requirements before prescribing or dispensing these formulations.

Caveats

• This is a regulatory approval record; it does not contain clinical trial results, efficacy data, or safety outcome comparisons
• The specific REMS modifications or requirements are not detailed in this summary record
• No patient population, sample size, or outcome data are reported
• The record does not indicate whether this approval is for a new indication, new formulation, or revised labelling

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.

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