Vigabatrin · Regulatory label update

FDA supplemental approval: Vigabatrin (REMS)

U.S. Food and Drug Administration · March 18, 2026

Regulatory Update Why this matters to you Expert discussion

An action by a regulator. Authoritative on labelling and availability.

AI Summary

The FDA issued a supplemental approval on 2026-03-18 for vigabatrin 500 mg tablets under a REMS (Risk Evaluation and Mitigation Strategy), submitted by Zydus Lifesciences as an ANDA supplement. This is a regulatory action governing safety monitoring conditions; the record does not contain clinical efficacy, safety outcomes, or trial data.

What was studied

Regulatory label update.

Key findings

Supplemental REMS approval granted for vigabatrin 500 mg oral tablet formulation

Safety

This is a regulatory approval record, not a clinical trial; it does not report efficacy, safety outcomes, comparative benefit, or study results.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

FDA supplemental approval of vigabatrin under a Risk Evaluation and Mitigation Strategy (REMS), a regulatory action governing drug safety monitoring and use conditions rather than efficacy evidence.

Reported figures

Quoted from the source exactly as published.

Approval date2026-03-18

Dosage form and strengthVIGABATRIN, TABLET, ORAL, 500MG

Submission typeSUPPL (REMS)

Caveats

This is a regulatory approval record, not a clinical trial; it does not report efficacy, safety outcomes, comparative benefit, or study results.
The specific changes or additions to the REMS program are not detailed in this record.
No clinical data, trial design, sample size, or outcome metrics are 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.

Study design

insufficient

Regulatory action record; no clinical study design present.

Directness

insufficient

Record does not report clinical outcomes or comparative efficacy data.

Consistency

insufficient

Single regulatory action; no comparison or replication data provided.

Risk of bias

insufficient

Not applicable to regulatory approval; no trial data to assess.

Sample adequacy

insufficient

No human subject study or sample reported in this record.

Source abstract

Drugs@FDA record for application ANDA215707. This is a regulatory action record, not a clinical study. Brand name: VIGABATRIN. Active ingredient: VIGABATRIN. Sponsor: ZYDUS LIFESCIENCES. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-03-18. Products: VIGABATRIN, TABLET, ORAL, VIGABATRIN 500MG.

Follow from this

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

Zydus LifesciencesVigabatrin