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): 211172
Company: AKCEA THERAPS

Medication Guide

REMS

Products on NDA 211172

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TEGSEDI	INOTERSEN SODIUM	EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)	SOLUTION;SUBCUTANEOUS	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 211172

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/05/2018	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211172lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/211172Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211172Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/22/2024	SUPPL-15	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/211172Orig1s015ltr.pdf
01/12/2024	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211172s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/211172Orig1s014ltr.pdf
03/08/2023	SUPPL-12	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211172Orig1s012ltr.pdf
03/31/2022	SUPPL-11	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211172Orig1s011ltr.pdf
06/17/2022	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211172s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211172Orig1s010ltr.pdf
07/30/2020	SUPPL-8	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211172s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211172Orig1s008ltr.pdf
05/11/2020	SUPPL-6	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211172Orig1s006ltr.pdf
10/25/2019	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211172s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211172Orig1s004ltr.pdf

Labels for NDA 211172

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/12/2024	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211172s014lbl.pdf
06/17/2022	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211172s010lbl.pdf
07/30/2020	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211172s008lbl.pdf
07/30/2020	SUPPL-8	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211172s008lbl.pdf
10/25/2019	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211172s004lbl.pdf
10/05/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211172lbl.pdf

Top