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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Pretomanid
Trade Name: Pretomanid
Date Designated: 07/05/2007
Orphan Designation: Treatment of tuberculosis
Orphan Designation Status: Designated/Approved
Global Alliance for TB Drug Development
80 Pine Street, 20th Floor
New York, New York 10005
United States

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

Marketing approved:

1 Generic Name: Pretomanid
Trade Name: Pretomanid
Marketing Approval Date: 08/14/2019
Approved Labeled Indication: Pretomanid tablet is indicated, as part of a combination regimen with bedaquiline and linezolid for the treatment of adults with pulmonary extensively drug resistant (XDR) or treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB).
Exclusivity End Date: 08/14/2026 
Exclusivity Protected Indication* :  As part of a combination regimen with bedaquiline and linezolid for the treatment of adults with pulmonary extensively drug resistant (XDR) or treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB).
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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