FDA supplemental approval: Acetaminophen, Caffeine AND Dihydrocodeine Bitartrate (REMS)

AI Summary

The FDA approved a supplemental application (ANDA204209) on 18 June 2026 imposing a Risk Evaluation and Mitigation Strategy (REMS) for a combination product containing acetaminophen 325 mg, caffeine 30 mg, and dihydrocodeine bitartrate 16 mg. This regulatory action documents the requirement for additional risk management measures but does not present clinical trial results, efficacy data, or comparative safety evidence.

Plain-language summary

This is an FDA supplemental approval action establishing a Risk Evaluation and Mitigation Strategy (REMS) for a combination opioid-analgesic product; it documents a regulatory decision, not clinical evidence of efficacy or safety.

Reported figures

Quoted from the source exactly as published.

Clinical bottom line

This record documents a regulatory requirement for REMS implementation but does not provide evidence to support clinical decision-making regarding efficacy, safety profile, or comparative benefit. Clinicians should refer to the full product labelling and REMS requirements for prescribing guidance.

Caveats

• This regulatory record does not contain clinical trial results, efficacy data, safety outcomes, or comparative evidence.
• The rationale for the REMS requirement and specific risk mitigation measures are not detailed in this record.
• Population characteristics, indications, and clinical endpoint data are not reported.
• No information on prior approval history, non-clinical studies, or the basis for the supplemental submission is provided.

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.

Follow from this

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