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Lemtrada Approval History

  • FDA approved: Yes (First approved November 14th, 2014)
  • Brand name: Lemtrada
  • Generic name: alemtuzumab
  • Dosage form: Injection
  • Company: Genzyme Corporation
  • Treatment for: Multiple Sclerosis

Lemtrada (alemtuzumab) is a CD52-directed cytolytic monoclonal antibody indicated for the treatment of relapsing forms of multiple sclerosis (MS).

Development History and FDA Approval Process for Lemtrada

Nov 14, 2014Approval FDA Approves Lemtrada (alemtuzumab) for Relapsing Forms of Multiple Sclerosis
Dec 30, 2013Genzyme Receives Complete Response Letter from FDA on Lemtrada (alemtuzumab) Application
Jan 28, 2013Genzyme's Lemtrada (alemtuzumab) Application for MS Accepted for Review by the FDA
Aug 27, 2012Genzyme Provides Update on U.S. Lemtrada Filing
Jun 12, 2012Genzyme Submits Applications to FDA and EMA for Approval of Lemtrada (alemtuzumab) for Multiple Sclerosis

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