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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

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.