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Tavalisse FDA Approval History

FDA Approved: Yes (First approved April 17, 2018)
Brand name: Tavalisse
Generic name: fostamatinib
Dosage form: Tablets
Company: Rigel Pharmaceuticals, Inc.
Treatment for: Idiopathic Thrombocytopenic Purpura

Tavalisse (fostamatinib) is an oral spleen tyrosine kinase (SYK) inhibitor for the treatment of patients with chronic immune thrombocytopenia (ITP).

Development Timeline for Tavalisse

DateArticle
Apr 17, 2018Approval FDA Approves Tavalisse (fostamatinib disodium hexahydrate) for Chronic Immune Thrombocytopenia
Apr  3, 2018Rigel Announces Topline Data from Proof-of-Concept Phase 2 Study of Fostamatinib in IgA Nephropathy
Oct  2, 2017Rigel Provides Update on FDA Review of Fostamatinib for ITP
Jun 19, 2017FDA Accepts Rigel's New Drug Application for Tavalisse (fostamatinib disodium) for the Treatment of Chronic ITP
Apr 27, 2017Rigel Announces Tavalisse as Proprietary Name for Fostamatinib in the United States
Apr 17, 2017Rigel Submits New Drug Application to FDA for Fostamatinib in Chronic ITP

Further information

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