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Brivaracetam · Regulatory approval
U.S. Food and Drug Administration · July 13, 2026
An action by a regulator. Authoritative on labelling and availability.
The FDA approved an original application (ANDA 219766) for brivaracetam intravenous solution 10 mg/mL (50 mg/5 mL vial) manufactured by Shandong on 13 July 2026. This is a regulatory action authorizing a new formulation and does not contain clinical trial results or efficacy data.
Regulatory approval. Intervention: Brivaracetam intravenous solution, 10 mg/mL (50 mg/5 mL vial).
FDA approval granted for brivaracetam intravenous solution formulation, 10 mg/mL concentration
This regulatory record does not contain clinical trial results, efficacy data, or safety outcomes.
The source did not state who this applies to in practice.
FDA approval of an intravenous brivaracetam formulation; this is a regulatory action authorizing a new drug product, not a clinical trial outcome.
As stated by the source record.
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.
Drugs@FDA record for application ANDA219766. This is a regulatory action record, not a clinical study. Brand name: BRIVARACETAM. Active ingredient: BRIVARACETAM. Sponsor: SHANDONG. Submission type: ORIG (original application). Approval status date: 2026-07-13. Products: BRIVARACETAM, SOLUTION, INTRAVENOUS, BRIVARACETAM 50MG/5ML (10MG/ML).
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.