Arzerra Approval History

  • FDA approved: Yes (First approved October 26th, 2009)
  • Brand name: Arzerra
  • Generic name: ofatumumab
  • Company: GlaxoSmithKline
  • Treatment for: Chronic Lymphocytic Leukemia

Arzerra (ofatumumab) is a CD20-directed cytolytic monoclonal antibody indicated for the treatment of patients with chronic lymphocytic leukemia.

FDA Approval History for Arzerra

DateArticle
Oct 26, 2009Approval FDA Approves Arzerra (ofatumumab) for Chronic Lymphocytic Leukemia
Jun 16, 2009FDA Extends Review of Arzerra (ofatumumab)
May 29, 2009GSK/Genmab Receive Favorable Recommendation for Arzerra from FDA Advisory Panel
May  4, 2009FDA Advisory Committee to Review Arzerra (Ofatumumab)
Apr  3, 2009Arzerra (Ofatumumab) Granted Priority Review By FDA
Jan 30, 2009GlaxoSmithKline and Genmab Submit Arzerra (Ofatumumab) Application to FDA for the Treatment of Advanced Stage Blood Cancer

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