Posted by Michael Wonder on 19 Aug 2020
Mylan brings critical access to the multiple sclerosis community by launching a more affordable treatment option through a first generic to Tecfidera
19 August 2020 - Mylan today announced the launch of the first FDA approved therapeutically equivalent, substitutable generic of Biogen's Tecfidera capsules.
Dimethyl fumarate delayed release capsules 120 mg and 240 mg are indicated for the treatment of relapsing forms of multiple sclerosis, and are the first generic of any multiple sclerosis treatment in an oral solid dosage form available to patients in the U.S.
The FDA approval follows Mylan's win in the U.S. District Court for the Northern District of West Virginia that invalidated Biogen's Tecfidera patent, U.S. Patent No. 8,399,514. Biogen is appealing that decision.
