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Tecfidera Approval History

  • FDA approved: Yes (First approved March 27th, 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 History and FDA Approval Process 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

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