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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: triclabendazole
Trade Name: Egaten
Date Designated: 04/17/2017
Orphan Designation: Treatment of fascioliasis
Orphan Designation Status: Designated/Approved
Novartis Pharmaceuticals Corporation
1 Health Plaza
East Hanover, New Jersey 07936
United States

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

Marketing approved:

1 Generic Name: triclabendazole
Trade Name: Egaten
Marketing Approval Date: 02/13/2019
Approved Labeled Indication: EGATEN¿ is indicated for the treatment of fascioliasis in patients 6 years of age and older.
Exclusivity End Date: 02/13/2026 
Exclusivity Protected Indication* :  EGATEN¿ is indicated for the treatment of fascioliasis in patients 6 years of age and older.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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