> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Sanofi Aubagio Data ‘Not Sufficient’ for New Indication: FDA
- URL: https://www.fdaweb.com/sanofi-aubagio-data-not-sufficient-for-new-indication-fda/
- Published: 2021-06-15T12:00:00.000Z
- Updated: 2026-09-14T17:03:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149539

In a complete response letter for Sanofi’s sNDA for Aubagio (teriflunomide) for children and adolescents 10 to 17 years old with relapsing forms of multiple sclerosis, FDA said the data submitted were not sufficient to obtain approval of an indication in the pediatric population at this time. Sanofi [says](https://www.sanofi.com/en/media-room/press-releases/2021/2021-06-11-07-00-00-2245628?ref=fdaweb.com) FDA updated the Aubagio labeling to include safety data from the pediatric trial program. The indicated use of the drug in patients 18 years and older remains unchanged, the company says.