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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-[(6-{[(2,6-Dichloro-3,5-dimethoxyphenyl)carbamoyl](methyl)amino}pyrimidin-4- yl)amino]-5-(4-ethylpiperazin-1-yl)phenyl}prop-2-enamide)
Date Designated: 09/07/2017
Orphan Designation: Treatment of hepatocellular carcinoma (HCC)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Eisai Inc.
200 Metro Blvd.
Nutley, New Jersey 07110-6102
United States

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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