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Home » EU Approves Sanofi’s Aubagio for Children and Adolescents With MS Following FDA’s Rejection
EU Approves Sanofi’s Aubagio for Children and Adolescents With MS Following FDA’s Rejection
The EU has approved Sanofi’s Aubagio (teriflunomide) for use in children and adolescents with multiple sclerosis — just days after the FDA issued the company a Complete Response Letter regarding its supplemental New Drug Application (sNDA) for Aubagio, rejecting its use in children and adolescents ages 10 to 17 years and requesting more pediatric data.