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FDA NDA · NDA205837

BRIVIACT

brivaracetam

Sponsor: UCB INC

APPLICATION
NDA205837
TYPE
NDA
ORIGINAL APPROVAL
2016-02-18
LATEST ACTION
2025-08-28
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

BRIVIACT · ReferencePrescription
BRIVARACETAM 50MG/5ML (10MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2025-08-28Labeling · Supplement 14 · standard — Letter ↗AP
2023-05-17Labeling · Supplement 11 · standard — Label ↗AP
2021-09-02Labeling · Supplement 9 · standard — Letter ↗AP
2021-08-27Efficacy · Supplement 7 · standard — Letter ↗AP
2018-05-10Labeling · Supplement 4 · standard — Label ↗AP
2017-09-14Efficacy · Supplement 3 · 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

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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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