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Rigel and Medison announce Health Canada approval of Tavalisse, an oral medication for the treatment of chronic immune thrombocytopenia.
Rigel Pharmaceuticals, Inc. and Medison Pharma announced that Health Canada has approved the new drug submission (NDS) for Tavalisse (fostamatinib disodium hexahydrate) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to other treatments.
In October 2019, Rigel entered into exclusive license agreements with Medison to commercialize Tavalisse in Canada and Israel. With the approval from Health Canada, Medison intends to launch Tavalisse in Canada in Q1 2021. In Israel, a decision on the new drug application (NDA) is anticipated during Q2 2021.
Fostamatinib is commercially available in the U.S. under the brand name Tavalisse (fostamatinib disodium hexahydrate) tablets, which is the first and only spleen tyrosine kinase (SYK) inhibitor indicated for the treatment of thrombocytopenia in adult patients with chronic ITP who have had an insufficient response to a previous treatment..
Condition: Immune Thrombocytopenic Purpura
Type: drug