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FDA NDA · NDA211172

TEGSEDI

Sponsor: AKCEA THERAPS

APPLICATION
NDA211172
TYPE
NDA
ORIGINAL APPROVAL
2018-10-05
LATEST ACTION
2024-11-22
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

TEGSEDI · ReferenceDiscontinued
INOTERSEN SODIUM EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) · SOLUTION · SUBCUTANEOUS

Approval history

2024-11-22REMS · Supplement 15 — Letter ↗AP
2024-01-12Labeling · Supplement 14 · standard — Letter ↗AP
2023-03-08REMS · Supplement 12 — Letter ↗AP
2022-06-17Labeling · Supplement 10 · standard — Label ↗AP
2022-03-31REMS · Supplement 11 — Letter ↗AP
2020-07-30Labeling · Supplement 8 · standard — Letter ↗AP
2020-05-11REMS · Supplement 6 — Letter ↗AP
2019-10-25Labeling · Supplement 4 · standard — Label ↗AP
2018-10-05Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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