Loading
Levetiracetam · Regulatory label update
U.S. Food and Drug Administration · April 21, 2026
An action by a regulator. Authoritative on labelling and availability.
The FDA approved a supplemental labeling change for levetiracetam oral solution 100 mg/mL on 21 April 2026. This regulatory action documents a label modification but does not report clinical trial results, efficacy data, or safety findings.
Regulatory label update.
The FDA approved a supplemental labeling change for levetiracetam oral solution 100 mg/mL on 21 April 2026. This regulatory action documents a label modification but does not report clinical trial results, efficacy data, or safety findings.
This record does not contain clinical trial results, efficacy data, or safety outcomes.
The source did not state who this applies to in practice.
This is an FDA supplemental approval for a labeling change to levetiracetam oral solution; it documents a regulatory action, not clinical trial evidence.
Quoted from the source exactly as published.
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.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Drugs@FDA record for application ANDA078582. This is a regulatory action record, not a clinical study. Brand name: LEVETIRACETAM. Active ingredient: LEVETIRACETAM. Sponsor: STRIDES PHARMA. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-04-21. Products: LEVETIRACETAM, SOLUTION, ORAL, LEVETIRACETAM 100MG/ML.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.