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Soliris Approval History

  • FDA approved: Yes (First approved March 16th, 2007)
  • Brand name: Soliris
  • Generic name: eculizumab
  • Company: Alexion Pharmaceuticals, Inc.
  • Treatment for: Paroxysmal Nocturnal Hemoglobinuria

Soliris (eculizumab) is a monoclonal antibody indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, and for the treatment of patients with atypical hemolytic uremic syndrome.

FDA Approval History for Soliris

DateArticle
Sep 23, 2011Approval Soliris (eculizumab) Approved by FDA for All Patients with Atypical Hemolytic Uremic Syndrome (aHUS)
Mar 19, 2007Approval FDA Approves Alexion's Soliris for All Patients With PNH
Nov 14, 2006FDA Grants Priority Review for Soliris (eculizumab) BLA for Treatment of Paroxysmal Nocturnal Hemoglobinuria
Sep 20, 2006Alexion Pharmaceuticals Submits Biologics License Application for Soliris (eculizumab)

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