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11-Jun-2021

Sanofi provides update on Aubagio® (teriflunomide) submission for children and adolescents with relapsing-remitting multiple sclerosis in the U.S.

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter regarding the supplemental New Drug Application for Aubagio┬« (teriflunomide) for children and adolescents 10 to 17 years of age with relapsing forms of multiple sclerosis.

The FDA deemed the data submitted were not sufficient to obtain approval of an indication in the pediatric population at this time. The FDA updated the Aubagio label to include safety data from the pediatric clinical trial program. The indicated use of Aubagio in patients 18 years and older remains unchanged.

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Last Updated: 11-Jun-2021