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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: fexinidazole
Trade Name:
Date Designated: 04/04/2016
Orphan Designation: Treatment of human African trypanosomiasis (HAT) or sleeping sickness
Orphan Designation Status: Designated/Approved
Sanofi US Services Inc., A SANOFI COMPANY
55 Corporate Drive
Bridgewater, New Jersey 08807-5925
United States

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

Marketing approved:

1 Generic Name: fexinidazole
Trade Name:
Marketing Approval Date: 07/16/2021
Approved Labeled Indication: Treatment of both the first-stage (hemolymphatic) and second-stage (meningoencephalitic) human African trypanosomiasis (HAT) due to Trypanosoma brucei gambiense in patients 6 years of age and older and weighing at least 20 kg. Limitations of use: Due to the decreased efficacy observed in patients with severe second stage HAT (cerebrospinal fluid white blood cell count (CSF-WBC) >100 cells/?L) due to T. brucei gambiense disease, Fexinidazole Tablets should only be used in these patients if there are no other available treatment options.
Exclusivity End Date: 07/16/2028 
Exclusivity Protected Indication* :  Treatment of both the first-stage (hemolymphatic) and second-stage (meningoencephalitic) human African trypanosomiasis (HAT) due to Trypanosoma brucei gambiense in patients 6 years of age and older and weighing at least 20 kg. Limitations of use: Due to the decreased efficacy observed in patients with severe second stage HAT (cerebrospinal fluid white blood cell count (CSF-WBC) >100 cells/?L) due to T. brucei gambiense disease, Fexinidazole Tablets should only be used in these patients if there are no other available treatment options.

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