Dimethyl Fumarate Newbury approved by the Swedish Health Authorities
Newbury Pharmaceuticals is pleased to announce the Marketing Authorization (MA) of Dimethyl Fumarate Newbury 120 & 240 mg hard capsule in Sweden as the first country in a Scandinavian registration procedure. Approvals in Norway and Denmark are expected to follow upon finalized national reviews.
“The approval of Dimethyl Fumarate Newbury is the 3rd product approved for the treatment of multiple sclerosis following the approval of Teriflunomide Newbury and Fampridine Newbury during the last quarter of 2022 and it further shows our commitment within the field of Neurology. Multiple sclerosis is a serious life changing disease where the company aim to provide cost efficient alternatives to current treatments. Based on this positive progress, we will proceed to launch this product, within respective markets as soon as regulatory exclusivities and patents allow us.” Says Mr. Lars Minor, CEO of Newbury.
Dimethyl Fumarate Newbury is indicated for the treatment of relapsing remitting multiple sclerosis. Our product has been developed based on the reference brand Tecfidera.
MS is a disease of the nerves, in which inflammation destroys the protective sheath around the nerves. Multiple sclerosis is characterized by immune-mediated inflammation and neurodegeneration. It is a disease of unknown etiology.