Aubagio

Treats relapsing forms of multiple sclerosis (MS). NDA 202992, held by Sanofi Aventis US. Teriflunomide.

As of Nov 13, 2026, NDA 202992 (Aubagio), held by Sanofi Aventis US, was first approved by FDA on Sep 12, 2012, with 13 approved supplements and 0 published complete response letters.

First approved: Sep 12, 2012
Review: Standard
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

AUBAGIO is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below


Apr 30, 2021	Supplement 13Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jul 24, 2019	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 17, 2014	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 12, 2012	Original applicationNew molecular entity · Standard review	Approved	Review Summary Review Letter Label

Products

2 strengths and forms


Aubagio7MG · tablet;oral	Teriflunomide	RxReference drug
Aubagio14MG · tablet;oral	Teriflunomide	RxReference drug

All 14 submissions, including labeling and manufacturing supplements


Feb 11, 2026	Supplement 18Labeling · Standard review	Approved	Label Letter Medication Guide
Jun 10, 2024	Supplement 17Labeling · Standard review	Approved	Label Letter
Apr 30, 2021	Supplement 15Labeling · Standard review	Approved	Label Letter
Apr 30, 2021	Supplement 13Efficacy (new indication or use) · Standard review	Approved	Label Letter
Nov 6, 2020	Supplement 14Labeling · Standard review	Approved	Letter Label
Nov 6, 2020	Supplement 12Labeling · Standard review	Approved	Label Letter
Feb 28, 2020	Supplement 10Labeling · Standard review	Approved	Label Letter
Sep 6, 2019	Supplement 8Labeling · Standard review	Approved	Letter Label
Jul 24, 2019	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 19, 2017	Supplement 4Labeling · Standard review	Approved	Letter
Nov 29, 2016	Supplement 2Labeling · Standard review	Approved	Letter Label
Jun 2, 2016	Supplement 3Labeling · Standard review	Approved	Letter Label
Oct 17, 2014	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 12, 2012	Original applicationNew molecular entity · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 202992
Drugs@FDA: Overview at FDA
Company: sanofi-aventis US

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