Savaysa

Product manufactured by Daiichi Sankyo Inc.

Application Nr Approved Date Route Status External Links
NDA206316 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Savaysa Is A Factor Xa Inhibitor Indicated: To Reduce The Risk Of Stroke And Systemic Embolism (Se) In Patients With Nonvalvular Atrial Fibrillation (Nvaf) ( 1.1 ) Limitation Of Use For Nvaf Savaysa Should Not Be Used In Patients With Creatinine Clearance (Crcl) > 95 Ml/min Because Of Increased Risk Of Ischemic Stroke Compared To Warfarin At The Highest Dose Studied (60 Mg) ( 1.1 ) Savaysa Is Indicated For The Treatment Of Deep Vein Thrombosis (Dvt) And Pulmonary Embolism (Pe) Following 5 To 10 Days Of Initial Therapy With A Parenteral Anticoagulant ( 1.2 ) 1.1 Reduction In The Risk Of Stroke And Systemic Embolism In Nonvalvular Atrial Fibrillation Savaysa Is Indicated To Reduce The Risk Of Stroke And Systemic Embolism (Se) In Patients With Nonvalvular Atrial Fibrillation (Nvaf). Limitation Of Use For Nvaf Savaysa Should Not Be Used In Patients With Crcl > 95 Ml/min Because Of An Increased Risk Of Ischemic Stroke Compared To Warfarin [ See Dosage And Administr Ation ( 2.1 ), Warnings And Precautions ( 5.1 ) And Clinical Studies ( 14.1 ) ] . 1.2 Treatment Of Deep Vein Thrombosis And Pulmonary Embolism Savaysa Is Indicated For The Treatment Of Deep Vein Thrombosis (Dvt) And Pulmonary Embolism (Pe) Following 5 To 10 Days Of Initial Therapy With A Parenteral Anticoagulant.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Edoxaban Tosylate EDOXABAN TOSYLATE ZINC6427042

Comments