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FDA NDA · NDA205838

BRIVIACT

brivaracetam

Sponsor: UCB INC

APPLICATION
NDA205838
TYPE
NDA
ORIGINAL APPROVAL
2016-02-18
LATEST ACTION
2025-08-28
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

BRIVIACT · ReferencePrescription
BRIVARACETAM 10MG/ML · SOLUTION · ORAL

Approval history

2025-08-28Labeling · Supplement 15 · standard — Letter ↗AP
2023-05-17Labeling · Supplement 11 · standard — Label ↗AP
2021-09-02Labeling · Supplement 8 · standard — Letter ↗AP
2021-08-27Efficacy · Supplement 6 · standard — Letter ↗AP
2018-05-10Efficacy · Supplement 3 · standard — Label ↗AP
2017-09-14Efficacy · Supplement 2 · standard — Label ↗AP
2016-06-03Labeling · Supplement 1 · standard — Label ↗AP
2016-02-18Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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