Valproic Acid · Regulatory label update

FDA supplemental approval: Stavzor (Labeling)

U.S. Food and Drug Administration · March 31, 2026

Regulatory Update Why this matters to you Expert discussion

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

AI Summary

This is an FDA supplemental approval action for labeling of Stavzor (valproic acid delayed-release capsules) in three strengths (125 mg, 250 mg, 500 mg), dated 31 March 2026. The record confirms that none of these products were discontinued or withdrawn for safety or effectiveness reasons. No clinical trial results, comparative efficacy data, or safety findings are included in this regulatory filing.

What was studied

Regulatory label update.

Key findings

FDA approved supplemental labeling for Stavzor delayed-release capsules: 125 mg, 250 mg, and 500 mg strengths Federal Register determination: products were not discontinued or withdrawn for safety or effectiveness reasons

Safety

This regulatory record does not contain clinical trial results, efficacy data, safety outcomes, or comparative effectiveness information. Federal Register determination: products were not discontinued or withdrawn for safety or effectiveness reasons

Who this may help

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

Plain-language summary

FDA supplemental approval of labeling for Stavzor (valproic acid); no clinical trial data or efficacy claims are presented in this regulatory action record.

Reported figures

Quoted from the source exactly as published.

Approval date2026-03-31

Product strengths approved125 mg, 250 mg, 500 mg delayed-release capsules

Caveats

This regulatory record does not contain clinical trial results, efficacy data, safety outcomes, or comparative effectiveness information.
The record documents only a labeling supplement approval; no new clinical evidence or study data are presented.
Specific labeling changes or additions are not detailed in this filing summary.

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

This is a regulatory filing, not a clinical study.

Directness

insufficient

Record does not report clinical outcomes or comparative effectiveness data.

Consistency

insufficient

No comparative or outcome data provided in this regulatory document.

Risk of bias

insufficient

Not applicable; this is a regulatory labeling action, not a study.

Sample adequacy

insufficient

No study population or sample size reported.

Source abstract

Drugs@FDA record for application NDA022152. This is a regulatory action record, not a clinical study. Brand name: STAVZOR. Active ingredient: VALPROIC ACID. Sponsor: BIONPHARMA. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-03-31. Products: STAVZOR, CAPSULE, DELAYED RELEASE, ORAL, VALPROIC ACID 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; STAVZOR, CAPSULE, DELAYED RELEASE, ORAL, VALPROIC ACID 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; STAVZOR, CAPSULE, DELAYED RELEASE, ORAL, VALPROIC ACID 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**.

Follow from this

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

BionpharmaValproic Acid