Aptiom

Treats partial-onset seizures. NDA 22416, held by Sumitomo Pharma Am. Eslicarbazepine Acetate.

As of Nov 14, 2026, NDA 22416 (Aptiom), held by Sumitomo Pharma Am, was first approved by FDA on Nov 8, 2013, with 8 approved supplements and 0 published complete response letters.

First approved: Nov 8, 2013
Review: Standard
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

APTIOM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below


Mar 15, 2019	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Letter Label Medication Guide
Sep 13, 2017	Supplement 9Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric CDTL Review Pediatric Medical Review
Aug 27, 2015	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Letter Label
Nov 8, 2013	Original applicationNew molecular entity · Standard review	Approved	Review Summary Review Label Letter

Products

4 strengths and forms


Aptiom200MG · tablet;oral	Eslicarbazepine Acetate	RxReference drug
Aptiom400MG · tablet;oral	Eslicarbazepine Acetate	RxReference drug
Aptiom600MG · tablet;oral	Eslicarbazepine Acetate	RxReference drug
Aptiom800MG · tablet;oral	Eslicarbazepine Acetate	RxReference drug

All 9 submissions, including labeling and manufacturing supplements


Jun 20, 2024	Supplement 21Manufacturing	Approved	Label Letter
Mar 15, 2019	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Letter Label Medication Guide
Sep 13, 2017	Supplement 9Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric CDTL Review Pediatric Medical Review
Mar 7, 2017	Supplement 6Labeling · Standard review	Approved	Letter
Jan 6, 2016	Supplement 5Manufacturing · Standard review	Approved	None posted
Sep 10, 2015	Supplement 4Manufacturing · Standard review	Approved	None posted
Aug 27, 2015	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jun 11, 2015	Supplement 2Manufacturing · Standard review	Approved	None posted
Nov 8, 2013	Original applicationNew molecular entity · Standard review	Approved	Review Summary Review Label Letter

Identifiers

Application: NDA 22416
Drugs@FDA: Overview at FDA
Company: Sumitomo Pharma America

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