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Drugs@FDA: FDA-Approved Drugs

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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	Prescription	None	Yes	Yes

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
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-Medication Guide, Labeling-Package Insert	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-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211172s008lbl.pdf
07/30/2020	SUPPL-8	Labeling-Package Insert	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

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