Imbruvica Approval History

• FDA approved: Yes (First approved November 13th, 2013)
• Brand name: Imbruvica
• Generic name: ibrutinib
• Company: Janssen Pharmaceuticals, Inc.
• Treatment for: Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia

Imbruvica (ibrutinib) is an oral Bruton's tyrosine kinase (BTK) inhibitor for the treatment of mantle cell lymphoma, chronic lymphocytic leukemia, and Waldenström’s macroglobulinemia.

Development History and FDA Approval Process for Imbruvica

Date	Article
Mar  4, 2016	FDA Approves Imbruvica (ibrutinib) for the First-Line Treatment of Chronic Lymphocytic Leukemia
Jan 29, 2015	FDA Expands Approved Use of Imbruvica for Waldenström’s Macroglobulinemia
Jul 28, 2014	FDA Expands Approved Use of Imbruvica for Chronic Lymphocytic Leukemia
Feb 12, 2014	FDA Approves Imbruvica to Treat Chronic Lymphocytic Leukemia
Nov 13, 2013	FDA Approves Imbruvica for Mantle Cell Lymphoma
Aug 29, 2013	New Drug Application Filing for Ibrutinib Accepted in Two B-cell Malignancies by the U.S. FDA
Jul 10, 2013	New Drug Application Submitted to U.S. FDA for Ibrutinib in the Treatment of Two B-Cell Malignancies

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