Brivaracetam

Treats partial-onset seizures. ANDA 214748, held by Sunshine. Brivaracetam.

As of Nov 15, 2026, ANDA 214748 (Brivaracetam), held by Sunshine, was first approved by FDA on Jun 9, 2022, with 2 approved supplements and 0 published complete response letters.

First approved: Jun 9, 2022
Review: Standard
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Brivaracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Jun 9, 2022	Original application	Approved	Letter

Products

5 strengths and forms


Brivaracetam10MG · tablet;oral	Brivaracetam	Rx
Brivaracetam25MG · tablet;oral	Brivaracetam	Rx
Brivaracetam50MG · tablet;oral	Brivaracetam	Rx
Brivaracetam75MG · tablet;oral	Brivaracetam	Rx
Brivaracetam100MG · tablet;oral	Brivaracetam	Rx

All 3 submissions, including labeling and manufacturing supplements


Jan 30, 2026	Supplement 3Labeling · Standard review	Approved	None posted
Jan 30, 2026	Supplement 4Labeling · Standard review	Approved	None posted
Jun 9, 2022	Original application	Approved	Letter

Identifiers

Application: ANDA 214748
Drugs@FDA: Overview at FDA
Company: Sunshine

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters