teriflunomide

FDA Drug Profile — Aubagio, teriflunomide

Drug Details

Generic Name
teriflunomide
Brand Names
Aubagio, teriflunomide
Application Number
NDA202992
Sponsor
OPELLA HEALTHCARE INTERNATIONAL SAS
NDC Codes
10
Dosage Forms
TABLET, FILM COATED, POWDER
Routes
ORAL
Active Ingredients
TERIFLUNOMIDE

Indications and Usage

1 INDICATIONS AND USAGE Teriflunomide tablet 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. Teriflunomide is a pyrimidine synthesis inhibitor 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. ( 1 )