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Zydelig Approval History

FDA Approved: Yes (First approved July 23, 2014)
Brand name: Zydelig
Generic name: idelalisib
Dosage form: Tablets
Company: Gilead Sciences, Inc.
Treatment for: Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Follicular Lymphoma

Zydelig (idelalisib) is a phosphoinositide 3-kinase (PI3K) delta inhibitor for the treatment of chronic lymphocytic leukemia, relapsed follicular B-cell non-Hodgkin lymphoma, and relapsed small lymphocytic lymphoma.

Development History and FDA Approval Process for Zydelig

DateArticle
Jul 23, 2014Approval FDA Approves Zydelig (idelalisib) for CLL and Lymphoma
Jan 13, 2014U.S. FDA Accepts New Drug Application for Gilead’s Idelalisib for the Treatment of Refractory Indolent Non-Hodgkin’s Lymphoma
Sep 11, 2013Gilead Submits New Drug Application to U.S. FDA for Idelalisib for the Treatment of Indolent Non-Hodgkin's Lymphoma

Further information

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