Bafiertam FDA Approval History
Last updated by Judith Stewart, BPharm on Sep 17, 2020.
FDA Approved: Yes (First approved April 28, 2020)
Brand name: Bafiertam
Generic name: monomethyl fumarate
Dosage form: Delayed-Release Capsules
Company: Banner Life Sciences LLC
Treatment for: Multiple Sclerosis
Bafiertam (monomethyl fumarate) is a novel fumarate 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.Bafiertam (monomethyl fumarate) is a bioequivalent alternative to Tecfidera (dimethyl fumarate). Dimethyl fumarate is considered to be a prodrug of monomethyl fumarate.
Development Timeline for Bafiertam
|Apr 30, 2020||Approval FDA Approves Bafiertam (monomethyl fumarate) for Multiple Sclerosis|
|Jan 2, 2019||Banner Receives FDA Tentative Approval for Bafiertam for the Treatment of Relapsing Forms of Multiple Sclerosis|
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.