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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Inotersen
Trade Name: TEGSEDI™
Date Designated: 07/24/2012
Orphan Designation: Treatment of transthyretin amyloidosis (ATTR amyloidosis)
Orphan Designation Status: Designated/Approved
Akcea Therapeutics, Inc.
22 Boston Wharf Road
9th Floor
Boston , Massachusetts 02210
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: Inotersen
Trade Name: TEGSEDI™
Marketing Approval Date: 10/05/2018
Approved Labeled Indication: TEGSEDI¿ is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.
Exclusivity End Date: 10/05/2025 
Exclusivity Protected Indication* :  TEGSEDI¿ is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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