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Vigabatrin · Regulatory label update
U.S. Food and Drug Administration · March 18, 2026
An action by a regulator. Authoritative on labelling and availability.
The FDA approved a supplemental application (REMS) for vigabatrin oral solution (500 mg/packet formulation) on 18 March 2026. This is a regulatory action to implement or modify a Risk Evaluation and Mitigation Strategy, not a report of new efficacy or safety trial data. The record does not disclose what the REMS requirements are, what safety signal prompted them, or comparative clinical outcomes.
Regulatory label update. Intervention: Vigabatrin 500 mg/packet, oral solution formulation.
FDA supplemental approval granted for vigabatrin 500 mg/packet oral solution formulation with REMS requirement, approval date 18 March 2026
This is a regulatory action record and does not contain clinical trial results, efficacy data, or detailed safety information. The specific REMS requirements, contraindications, monitoring parameters, or safety signals are not stated in this record.
This record indicates regulatory approval of a formulation with mandatory risk mitigation requirements. Clinicians should be aware that a REMS applies and must understand and comply with the program requirements; however, this record does not disclose the specific safety or efficacy data underlying the REMS or comparative clinical outcomes.
FDA supplemental approval for a REMS (Risk Evaluation and Mitigation Strategy) program for vigabatrin; indicates regulatory action to manage known safety risks but does not report clinical trial data or efficacy.
As stated by the source record.
Quoted from the source exactly as published.
This record indicates regulatory approval of a formulation with mandatory risk mitigation requirements. Clinicians should be aware that a REMS applies and must understand and comply with the program requirements; however, this record does not disclose the specific safety or efficacy data underlying the REMS or comparative clinical outcomes.
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 ANDA211481. This is a regulatory action record, not a clinical study. Brand name: VIGABATRIN. Active ingredient: VIGABATRIN. Sponsor: DR REDDYS. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-03-18. Products: VIGABATRIN, FOR SOLUTION, ORAL, VIGABATRIN 500MG/PACKET.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.