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Aspirin · Regulatory label update
U.S. Food and Drug Administration · June 18, 2026
An action by a regulator. Authoritative on labelling and availability.
This is an FDA supplemental approval action granting a REMS (Risk Evaluation and Mitigation Strategy) designation to a hydrocodone bitartrate and aspirin combination tablet. The record documents regulatory authorization of the safety management framework for this product but does not contain clinical trial results, efficacy data, or comparative effectiveness evidence.
Regulatory label update. Patients eligible for hydrocodone bitartrate and aspirin combination therapy; REMS applies to all users of this product, but the specific clinical indication and population are not stated in this regulatory record.. Intervention: Hydrocodone bitartrate 5 mg and aspirin 500 mg combination tablet, oral.
Supplemental REMS approval granted for hydrocodone bitartrate 5 mg and aspirin 500 mg oral tablet formulation on 2026-06-18
This record does not contain clinical trial results, efficacy data, or safety outcome measures No comparative effectiveness, adverse event rates, or contraindication updates are reported
Clinicians should be aware that this product now carries an FDA-mandated REMS program, which typically includes prescriber and/or patient requirements (e.g., education, monitoring, restricted dispensing). Consult the full REMS documentation for specific requirements. This approval does not establish efficacy or safety new to the product; it formalizes the risk mitigation framework.
FDA supplemental approval action establishing a REMS (Risk Evaluation and Mitigation Strategy) for an existing hydrocodone bitartrate and aspirin combination product; this record documents regulatory authorization but does not report clinical trial outcomes or efficacy data.
As stated by the source record.
Quoted from the source exactly as published.
Clinicians should be aware that this product now carries an FDA-mandated REMS program, which typically includes prescriber and/or patient requirements (e.g., education, monitoring, restricted dispensing). Consult the full REMS documentation for specific requirements. This approval does not establish efficacy or safety new to the product; it formalizes the risk mitigation framework.
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.
Drugs@FDA record for application ANDA205479. This is a regulatory action record, not a clinical study. Brand name: HYDROCODONE BITARTRATE AND ASPIRIN. Active ingredient: ASPIRIN. Sponsor: LGM PHARMA. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-06-18. Products: HYDROCODONE BITARTRATE AND ASPIRIN, TABLET, ORAL, ASPIRIN 500MG + HYDROCODONE BITARTRATE 5MG.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.