Savaysa

Product manufactured by Daiichi Sankyo, Inc.

Application Nr Approved Date Route Status External Links
NDA206316 2015-01-08 Oral RX 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 Administration (2.1), Warnings And Precautions (5.1), 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 (2 Total)

Name Structure Kind Function Status
1. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
2. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

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

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