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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: revakinagene taroretcel-lwey
Trade Name: Encelto
Date Designated: 07/24/2012
Orphan Designation: Treatment of macular telangiectasia type 2 (MacTel)
Orphan Designation Status: Designated/Approved
Neurotech Pharmaceuticals, Inc.
900 Highland Corporate Drive
Building #1, Suite #101
Cumberland, Rhode Island 02864
United States

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

Marketing approved:

1 Generic Name: revakinagene taroretcel-lwey
Trade Name: Encelto
Marketing Approval Date: 03/05/2025
Approved Labeled Indication: treatment of adults with idiopathic macular telangiectasia type 2 (MacTel)
Exclusivity End Date: 03/05/2032 
Exclusivity Protected Indication* :  treatment of adults with idiopathic macular telangiectasia type 2 (MacTel)
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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