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Soliris Approval History

  • FDA approved: Yes (First approved March 16th, 2007)
  • Brand name: Soliris
  • Generic name: eculizumab
  • Dosage form: Injection
  • 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.

Development History and FDA Approval Process for Soliris

Oct 23, 2017Approval FDA Approves Soliris (eculizumab) for the Treatment of Patients with Generalized Myasthenia Gravis (GMG)
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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