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