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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

DateArticle
Apr 30, 2020Approval  FDA Approves Bafiertam (monomethyl fumarate) for Multiple Sclerosis
Jan  2, 2019Banner Receives FDA Tentative Approval for Bafiertam for the Treatment of Relapsing Forms of Multiple Sclerosis

Further information

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