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Savaysa Approval History

FDA Approved: Yes (First approved January 8, 2015)
Brand name: Savaysa
Generic name: edoxaban
Dosage form: Tablets
Company: Daiichi Sankyo
Treatment for: Prevention of Thromboembolism in Atrial Fibrillation, Deep Vein Thrombosis, Pulmonary Embolism

Savaysa (edoxaban) is an oral, once-daily factor Xa inhibitor anticoagulant indicated for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, and for the treatment of deep vein thrombosis, and pulmonary embolism.

Development History and FDA Approval Process for Savaysa

DateArticle
Jan  8, 2015Approval FDA Approves Savaysa (edoxaban) to Prevent Embolic Events in Non-Valvular Atrial Fibrillation
Oct 31, 2014FDA Advisory Committee Recommends Savaysa (edoxaban) for Reduction of Embolic Events in Non-Valvular Atrial Fibrillation
Jan  8, 2014Daiichi Sankyo Submits Savaysa (edoxaban) New Drug Application to the U.S. FDA

Further information

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