An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 206316
Company: DAIICHI SANKYO INC

Medication Guide

FDA Press Release

Summary Review

Products on NDA 206316

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SAVAYSA	EDOXABAN TOSYLATE	EQ 15MG BASE	TABLET;ORAL	Prescription	None	Yes	No
SAVAYSA	EDOXABAN TOSYLATE	EQ 30MG BASE	TABLET;ORAL	Prescription	None	Yes	No
SAVAYSA	EDOXABAN TOSYLATE	EQ 60MG BASE	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 206316

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/08/2015	ORIG-2	Approval	Efficacy	STANDARD		Label is not available on this site.
01/08/2015	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206316lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206316Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206316Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206316Orig1Orig2s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206316Orig1Orig2s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/18/2023	SUPPL-21	Efficacy-Labeling Change With Clinical Data		Label is not available on this site.
09/11/2023	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206316Orig1s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/206316Orig1s020ltr.pdf
10/18/2023	SUPPL-19	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206316s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/206316Orig1s019ltr.pdf
11/01/2021	SUPPL-18	Labeling-Medication Guide	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/206316Orig1s018ltr.pdf
04/20/2021	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206316s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/206316Orig1s017ltr.pdf
04/21/2020	SUPPL-16	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206316s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/206316Orig1s016ltr.pdf
08/09/2019	SUPPL-15	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206316s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/206316Orig1s015ltr.pdf
09/29/2017	SUPPL-12	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206316s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206316Orig1s012ltr.pdf
04/25/2016	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
10/16/2015	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
11/06/2015	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
09/15/2016	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206316s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206316Orig1s004ltr.pdf
10/30/2015	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
09/10/2015	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206316s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206316Orig1s002ltr.pdf
08/24/2015	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 206316

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/18/2023	SUPPL-19	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206316s019lbl.pdf
09/11/2023	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206316Orig1s020lbl.pdf
04/20/2021	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206316s017lbl.pdf
04/21/2020	SUPPL-16	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206316s016lbl.pdf
04/21/2020	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206316s016lbl.pdf
08/09/2019	SUPPL-15	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206316s015lbl.pdf
09/29/2017	SUPPL-12	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206316s012lbl.pdf
09/15/2016	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206316s004lbl.pdf
09/10/2015	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206316s002lbl.pdf
01/08/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206316lbl.pdf

Top