Brivaracetam · Regulatory approval

FDA approval: Brivaracetam

U.S. Food and Drug Administration · July 1, 2026

Regulatory Update Why this matters to you Expert discussion

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

AI Summary

The FDA approved an abbreviated new drug application (ANDA) for generic brivaracetam tablets in four strengths (25 mg, 50 mg, 75 mg, 100 mg) from SCIEGEN PHARMS, effective 2026-07-01. This regulatory action establishes bioequivalence and pharmaceutical equivalence but does not report clinical efficacy, safety trial results, or comparative benefit data.

What was studied

Regulatory approval.

Key findings

Brivaracetam tablet formulations approved in four strengths: 25 mg, 50 mg, 75 mg, 100 mg

Safety

This record does not contain clinical trial results, efficacy data, or safety outcomes. Bioequivalence and pharmaceutical equivalence supporting the ANDA are not detailed in this record.

Who this may help

Clinicians may now prescribe generic brivaracetam from this manufacturer as an alternative to branded formulations. The approval does not provide new clinical evidence and practitioners should rely on existing literature regarding brivaracetam's efficacy and safety profile in seizure management.

Plain-language summary

FDA approval of a generic brivaracetam formulation; establishes regulatory authorization but does not report clinical trial data or comparative efficacy evidence.

Reported figures

Quoted from the source exactly as published.

Approval status date2026-07-01

Application typeANDA (abbreviated new drug application)

Clinical bottom line

Caveats

This record does not contain clinical trial results, efficacy data, or safety outcomes.
Bioequivalence and pharmaceutical equivalence supporting the ANDA are not detailed in this record.
No comparative safety or efficacy evidence versus brand-name brivaracetam is reported.
Patient population, indication, and clinical use criteria are not specified in this approval record.

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 record; no clinical study design reported.

Directness

insufficient

Record documents approval action, not clinical outcomes or patient populations.

Consistency

insufficient

No comparative data or consistency assessment provided in record.

Risk of bias

insufficient

Regulatory record does not assess or report trial methodology or bias.

Sample adequacy

insufficient

No sample size or trial enrollment data reported.

Source abstract

Drugs@FDA record for application ANDA219952. This is a regulatory action record, not a clinical study. Brand name: BRIVARACETAM. Active ingredient: BRIVARACETAM. Sponsor: SCIEGEN PHARMS. Submission type: ORIG (original application). Approval status date: 2026-07-01. Products: BRIVARACETAM, TABLET, ORAL, BRIVARACETAM 75MG; BRIVARACETAM, TABLET, ORAL, BRIVARACETAM 25MG; BRIVARACETAM, TABLET, ORAL, BRIVARACETAM 100MG; BRIVARACETAM, TABLET, ORAL, BRIVARACETAM 50MG.

Follow from this

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

Sciegen PharmsBrivaracetam