Search Orphan Drug Designations and Approvals
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Generic Name: | nifurtimox | ||||||||||||||||
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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 | ||||||||||||||||
Sponsor: |
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. |
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Marketing approved: |
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1 | Generic Name: | nifurtimox |
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Trade Name: | LAMPIT | |
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 | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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