Savaysa Tablet, Film Coated
Product Images NDC 65597-203

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Savaysa (NDC 65597-203). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Daiichi Sankyo Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Figure 6.1 (Savaysa 01)

A forest plot showing hazard ratios (HR) and 95% confidence intervals (CI) comparing Edoxaban Tosylate versus Warfarin across various subgroups including age, gender, weight, prior stroke/TIA, diabetes status, creatinine clearance, geographic region, and aspirin use at randomization. The horizontal axis indicates favorability from Edoxaban to Warfarin. Each subgroup is listed with sample size and event rates, accompanied by HR points and confidence intervals to illustrate relative risk differences.*

FDA Label Image

Chemical Structure (Savaysa 02)

Chemical structure of edoxaban tosylate, the active ingredient in SAVAYSA tablets. The diagram shows the molecular arrangement including functional groups and bond types associated with edoxaban tosylate, a blood anticoagulant agent.*

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Figure 12.1 (Savaysa 03)

A pharmacokinetic chart showing fold change and 90% confidence intervals in Cmax and AUC of Edoxaban Tosylate when coadministered with various interacting drugs, including P-gp inhibitors, P-gp inducers, and other drugs. The x-axis represents change relative to reference from 0 to 2.5, and the y-axis lists the interacting drugs by name and category.*

FDA Label Image

Figure 14.1 (Savaysa 04)

A line graph comparing the estimated cumulative proportion of patients experiencing stroke or systemic embolic events (SEE) over time in days between SAVAYSA 60 mg and Warfarin. The x-axis represents time to stroke or SEE (days), and the y-axis represents the estimated cumulative proportion of patients. The graph includes data on the number of patients at risk over various time points for both SAVAYSA and Warfarin groups.*

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Figure 14.2 (Savaysa 05)

A forest plot comparing hazard ratios with 95% confidence intervals for Edoxaban (SAVAYSA) versus Warfarin across various patient subgroups including age, gender, weight, prior stroke/TIA, diabetes, CHADS2 score, creatinine clearance, geographic region, and aspirin use. The plot depicts Edoxaban generally favored with hazard ratios mostly below 1.0, indicating relative risk differences between treatments.*

FDA Label Image

Figure 14.3 (Savaysa 06)

A line graph comparing the estimated cumulative proportion of adjudicated recurrent VTE over time (days) between SAVAYSA 60 mg and Warfarin. The x-axis shows time to recurrent VTE up to 360 days, and the y-axis shows the cumulative proportion. The graph includes patient risk numbers at multiple time points for both SAVAYSA and Warfarin groups.*

FDA Label Image

15 mg 30-count Bottle Label (Savaysa 07)

Label for Savaysa 15 mg tablets, oral film-coated tablets containing edoxaban tosylate. The label shows the proprietary name Savaysa and generic edoxaban. It indicates a quantity of 30 tablets and includes storage instructions. The product is manufactured by Daiichi Sankyo Inc., made in Japan, with an NDC of 65597-201-30.*

FDA Label Image

30 mg 30-count Bottle Label (Savaysa 08)

Savaysa 30 mg edoxaban tablets packaging label shows a box containing 30 film-coated oral tablets. The label indicates each tablet contains 30 mg edoxaban (equivalent to 40.41 mg edoxaban tosylate monohydrate). The product is manufactured for Daiichi Sankyo, Inc. and is marked Rx only.*

FDA Label Image

30 mg 90-count Bottle Label (Savaysa 09)

Packaging label for Savaysa 30 mg film coated tablets containing edoxaban tosylate. The label shows the Savaysa brand name with dosage strength prominently displayed as 30 mg in a yellow box, along with usage instructions stating 'For Hospital Use Only'. Manufactured by Daiichi Sankyo, the package contains 5 blister packs of 10 tablets each. The label also provides storage directions and includes barcodes.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.