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
9
Dosage Forms
TABLET, FILM COATED, POWDER
Routes
ORAL
Active Ingredients
TERIFLUNOMIDE

Indications and Usage

1 INDICATIONS AND USAGE Teriflunomide tablets are 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 tablets are 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 )