Search Orphan Drug Designations and Approvals
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Generic Name: | benznidazole | ||||||||||||||||
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Trade Name: | |||||||||||||||||
Date Designated: | 04/14/2014 | ||||||||||||||||
Orphan Designation: | Treatment of Chagas disease | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
Chemo Research, S.L. Edificio Nectar c/Quintanapalla, 2, 3 planta Madrid Spain The sponsor address listed is the last reported by the sponsor to OOPD. |
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Marketing approved: |
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1 | Generic Name: | benznidazole |
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Trade Name: | ||
Marketing Approval Date: | 08/29/2017 | |
Approved Labeled Indication: | Treatment of Chagas disease (American trypanosomiasis), caused by Trypanosoma cruzi, in pediatric patients 2 to 12 years of age. | |
Exclusivity End Date: | 08/29/2024 | |
Exclusivity Protected Indication* : | Treatment of Chagas disease (American trypanosomiasis), caused by Trypanosoma cruzi, in pediatric patients 2 to 12 years of age. | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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