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Tasigna Approval History

FDA Approved: Yes (First approved October 29, 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

DateArticle
Mar 22, 2018Approval Novartis Drug Tasigna Approved by FDA to Treat Children with Rare Form of Leukemia
Dec 22, 2017Approval FDA Updates the Label of Tasigna to Reflect that Certain Patients with a Type of Leukemia May be Eligible to Stop Treatment After Sustained Response
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

Further information

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