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Tysabri Approval History

FDA Approved: Yes (First approved November 23, 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

DateArticle
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

Further information

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