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
|Apr 17, 2018|| FDA Approves Tavalisse (fostamatinib disodium hexahydrate) for Chronic Immune Thrombocytopenia|
|Apr 3, 2018||Rigel Announces Topline Data from Proof-of-Concept Phase 2 Study of Fostamatinib in IgA Nephropathy|
|Oct 2, 2017||Rigel Provides Update on FDA Review of Fostamatinib for ITP|
|Jun 19, 2017||FDA Accepts Rigel's New Drug Application for Tavalisse (fostamatinib disodium) for the Treatment of Chronic ITP|
|Apr 27, 2017||Rigel Announces Tavalisse as Proprietary Name for Fostamatinib in the United States|
|Apr 17, 2017||Rigel Submits New Drug Application to FDA for Fostamatinib in Chronic ITP|
|Aug 30, 2016||Rigel's Fostamatinib Meets Primary Endpoint in Phase 3 Study in Chronic ITP|
|Feb 25, 2016||Rigel Initiates Phase 2 Clinical Trial of Fostamatinib in Autoimmune Hemolytic Anemia|
|Jun 4, 2013||Rigel Will Resume Responsibility for Fostamatinib Program|
|Jun 4, 2013||AstraZeneca: Will Return Fostamatinib Rights to Rigel Pharmaceuticals|
|Dec 13, 2012||AstraZeneca Announces Top-Line Results of OSKIRA-4 Phase IIb Study of Fostamatinib as a Monotherapy for Rheumatoid Arthritis|
|Sep 23, 2010||Data Published Today Reveal That Novel Oral Therapy Fostamatinib Demonstrates Positive Response in Rheumatoid Arthritis Patients|
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