Inotersen Sodium

Sold as Tegsedi. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 1 application for Inotersen Sodium (sold as Tegsedi), first approved Oct 5, 2018, with 0 new uses approved and 0 published complete response letters.

First approved: Oct 5, 2018
Applications: 1
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $0K
First approved in the EU: Jul 6, 2018

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Tegsedi	Part D	$0K	-100%	0

Orphan Designations (FDA)

One designation, 1 approved for the designated use; see all orphan designations

Treatment of transthyretin amyloidosis (ATTR amyloidosis)Akcea Therapeutics, Inc. · designated Jul 24, 2012 · approved Oct 5, 2018

Approvals in the EU (EMA)

First approved in the EU 3 months before the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Tegsedi, new substanceAkcea Therapeutics Ireland Limited · Jul 6, 2018

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Oct 5, 2018	TegsediNDA 211172 · New molecular entity	Akcea Theraps	8	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA