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Arzerra FDA Approval History

FDA Approved: Yes (First approved October 26, 2009)
Brand name: Arzerra
Generic name: ofatumumab
Dosage form: Injection
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.

Development timeline for Arzerra

Aug 31, 2016Approval Genmab Announces U.S. FDA Approval of Arzerra (ofatumumab) in Combination with Fludarabine and Cyclophosphamide for Relapsed CLL
Jan 19, 2016Approval Genmab Announces U.S. FDA Approval of Arzerra (ofatumumab) as Extended Treatment for Recurrent or Progressive CLL
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

Further information

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