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New Drug Application (NDA): 211172
Company: AKCEA THERAPS
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
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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