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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: 5-{[(3R,4R)-1-(4-chloro-2,6-difluorophenyl)-3,4-dihydroxypiperidin-4-yl]methoxy}-8-fluoro-3,4-dihydroquinolin-2(1H)-one
Date Designated: 12/05/2016
Orphan Designation: Treatment of active tuberculosis
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Otsuka Pharmaceutical Company, Ltd
2-9, Kanda-Tsukasamachi
Tokyo
Japan

The sponsor address listed is the last reported by the sponsor to OOPD.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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