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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  nifurtimox
Trade Name:  LAMPIT
Date Designated:  08/05/2010
Orphan Designation:  Treatment of Chagas disease (American Typanosomiasis)caused by T. cruzi
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  08/06/2020 
Approved Labeled Indication:  LAMPIT is indicated in pediatric patients (birth to less than 18 years of age and weighing at least 2.5 kg) for the treatment of Chagas disease (American Trypanosomiasis), caused by Trypanosoma cruzi
Exclusivity End Date:    08/06/2027 
Exclusivity Protected Indication* :  indicated in pediatric patients (birth to less than 18 years of age and weighing at least 2.5 kg) for the treatment of Chagas disease (American Trypanosomiasis) caused by Trypanosoma cruzi
Bayer HealthCare Pharmaceuticals, Inc.
100 BAYER BLVD
WHIPPANY, New Jersey 07981
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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