Teriflunomide Newbury approved by the Norwegian Health Authorities
Newbury Pharmaceuticals is pleased to announce the Marketing Authorization (MA) of Teriflunomide Newbury 14 mg film-coated divisible tablets in Norway as the first country in a Scandinavian registration procedure. Approvals in Sweden and Denmark are expected to follow upon finalized national reviews.
“Our product is a fully bioequivalent version of Aubagio 14mg film-coated tablets. Moreover, being a divisible tablet with one product, we can cover the 7 mg strength needed for the treatment of the pediatric population. Based on this positive progress, we will proceed to launch this product when regulatory exclusivities and patents allow us.” Says Mr. Lars Minor, CEO of Newbury.
Teriflunomide is a prescription drug indicated for treatment of relapsing forms of multiple sclerosis. Multiple sclerosis is characterized by immune-mediated inflammation and neurodegeneration. It is a disease of unknown etiology. Although the exact mechanism of action of teriflunomide in MS is not fully clear, it is thought to reduce the number of lymphocytes, thereby reducing inflammation and controlling the symptoms of the disease.
