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Tysabri Approval History

  • FDA approved: Yes (First approved November 23rd, 2004)
  • Brand name: Tysabri
  • Generic name: natalizumab
  • Dosage form: Injection
  • Previous name: Antegren
  • Company: Biogen Idec / Elan Corporation, plc
  • Treatment for: Multiple Sclerosis, Crohn's Disease, Maintenance

Tysabri (natalizumab) is a recombinant humanized IgG4κ monoclonal antibody for the treatment of multiple sclerosis and Crohn's disease.

Development History and FDA Approval Process for Tysabri

Jan 15, 2008Approval FDA Approves Tysabri to Treat Moderate-to-Severe Crohn's Disease
Oct 15, 2007Elan and Biogen Idec Announce That FDA Will Extend Regulatory Review Period for Tysabri for Crohn's Disease
Aug  1, 2007Joint FDA Advisory Committee Recommends Approval of Tysabri for the Treatment of Moderate to Severe Crohn's Disease
Nov 23, 2004Approval Tysabri Approved for Multiple Sclerosis
Jul 26, 2004FDA Accepts Biologics License Application for Antegren for Multiple Sclerosis
May 25, 2004Biogen Idec and Elan Submit Biologics License Application to the FDA for Approval of Antegren for Multiple Sclerosis Based on One-Year Data
Feb 18, 2004Biogen Idec and Elan Announce Intention to Submit for Approval for Multiple Sclerosis Based on One-Year Data

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