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Tasigna Approval History

  • FDA approved: Yes (First approved October 29th, 2007)
  • Brand name: Tasigna
  • Generic name: nilotinib
  • Dosage form: Capsules
  • Company: Novartis
  • Treatment for: Chronic Myelogenous Leukemia

Tasigna (nilotinib) is a kinase inhibitor indicated for the treatment of chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (CML).

Development History and FDA Approval Process for Tasigna

Jun 18, 2010Approval Novartis International AG (CH) - FDA approves Tasigna for newly diagnosed chronic myeloid leukemia patients, data demonstrate major advance over Glivec
Oct 29, 2007Approval Tasigna Receives US Approval Providing New Hope to Chronic Myeloid Leukemia Patients with Resistance or Intolerance to Existing Therapies

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