NDA 211172, held by Akcea Theraps. Inotersen Sodium.
As of Nov 13, 2026, NDA 211172 (Tegsedi), held by Akcea Theraps, was first approved by FDA on Oct 5, 2018, with 8 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 5, 2018 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| TegsediEQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) · solution;subcutaneous | Inotersen Sodium | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 22, 2024 | Supplement 15REMS | Approved | |
| Jan 12, 2024 | Supplement 14Labeling · Standard review | Approved | |
| Mar 8, 2023 | Supplement 12REMS | Approved | |
| Jun 17, 2022 | Supplement 10Labeling · Standard review | Approved | |
| Mar 31, 2022 | Supplement 11REMS | Approved | |
| Jul 30, 2020 | Supplement 8Labeling · Standard review | Approved | |
| May 11, 2020 | Supplement 6REMS | Approved | |
| Oct 25, 2019 | Supplement 4Labeling · Standard review | Approved | |
| Oct 5, 2018 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
