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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: elamipretide
Trade Name: Forzinity
Date Designated: 03/22/2018
Orphan Designation: Treatment of Barth syndrome
Orphan Designation Status: Designated/Approved
Stealth Biotherapeutics, Inc.
140 Kendrick Street
Building C-West
Needham, Massachusetts 02494
United States

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

Marketing approved:

1 Generic Name: elamipretide
Trade Name: Forzinity
Marketing Approval Date: 09/19/2025
Approved Labeled Indication: to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg
Exclusivity End Date: TBD  
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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