Savaysa FDA Approval History

FDA Approved: Yes (First approved January 8, 2015)
Brand name: Savaysa
Generic name: edoxaban
Dosage form: Tablets
Company: Daiichi Sankyo Inc.
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 timeline for Savaysa

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

Further information

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Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA

Savaysa FDA Approval History

Development timeline for Savaysa

See also

Further information