![From QSR to QMSR: Meeting FDA’s New Requirements From QSR to QMSR: Meeting FDA’s New Requirements](https://www.fdanews.com/ext/resources/Book-Covers-NEW/From-QSR-to-QMSR-500.png?height=200&t=1714569011&width=200)
Home » Mylan’s Generic Version of Biogen’s MS Drug Gets FDA Approval
Mylan’s Generic Version of Biogen’s MS Drug Gets FDA Approval
August 21, 2020
Mylan has received FDA approval for its generic version of Biogen’s Tecfidera (dimethyl fumarate), a blockbuster drug for treating relapsing forms of multiple sclerosis (MS).
The copycat drug, the first oral solid-dosage generic of any MS treatment to earn FDA approval, was caught up in a federal court case that ultimately led to the invalidation of Biogen’s Tecfidera patent and a Mylan victory.
Mylan has now launched the product in 120mg and 240mg delayed-release capsule forms.
Upcoming Events
-
21Oct