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Tecfidera FDA Approval History

FDA Approved: Yes (First approved March 27, 2013)
Brand name: Tecfidera
Generic name: dimethyl fumarate
Dosage form: Delayed-Release Capsules
Previous Name: BG-12
Company: Biogen Idec
Treatment for: Multiple Sclerosis

Tecfidera (dimethyl fumarate) is an oral Nrf2 pathway activator for the treatment of relapsing forms of multiple sclerosis.

Development timeline for Tecfidera

Mar 27, 2013Approval FDA Approves Tecfidera - a New Treatment for Multiple Sclerosis
Oct 18, 2012Biogen Idec Receives Notification of PDUFA Date Extension
May  9, 2012US and EU Regulatory Authorities Accept Oral BG-12 Marketing Applications for Review
Feb 28, 2012Biogen Idec Submits Application to FDA for Approval of Oral BG-12 to Treat Multiple Sclerosis

Further information

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