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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: N-{2-[4-(2-Amino-5-chloropyridin-3-yl)phenoxy]pyrimidin-5-yl}-N'-[2-(methanesulfonyl)-5-(trifluoromethyl)phenyl]urea mono-4-toluenesulfonate
Date Designated: 09/13/2017
Orphan Designation: Treatment of tropomyosin receptor kinase (Trk) gene fusion-positive cancer
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 10/03/2018
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Ono Pharmaceuticals Co. Ltd.
8-2, Kyutaromachi l-chome
Chuo-ku, Osaka-fu
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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