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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-[4-[[2-(1,1-Dimethylethyl)phenyl]sulfonyl]phenyl]-2,3,4-trihydroxy-5-[[2-(1-methylethyl)phenyl]methyl]benzamide
Date Designated: 09/14/2020
Orphan Designation: Treatment of retinoblastoma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Oxular Ltd
Magadalen Centre
1 Robert Robinson Avenue
Oxford OX4 4GA
United Kingdom

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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