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Tavalisse 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 History and FDA Approval Process 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
Aug 30, 2016Rigel's Fostamatinib Meets Primary Endpoint in Phase 3 Study in Chronic ITP
Feb 25, 2016Rigel Initiates Phase 2 Clinical Trial of Fostamatinib in Autoimmune Hemolytic Anemia
Jun  4, 2013Rigel Will Resume Responsibility for Fostamatinib Program
Jun  4, 2013AstraZeneca: Will Return Fostamatinib Rights to Rigel Pharmaceuticals
Dec 13, 2012AstraZeneca Announces Top-Line Results of OSKIRA-4 Phase IIb Study of Fostamatinib as a Monotherapy for Rheumatoid Arthritis
Sep 23, 2010Data Published Today Reveal That Novel Oral Therapy Fostamatinib Demonstrates Positive Response in Rheumatoid Arthritis Patients

Further information

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