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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: [6-(4-Chlorophenyl)-spiro[3.5]non-6-en-7-yl]methyl}-piperazin-1-yl}-N-{{3-nitro-4-[((2S)-1,4-dioxan-2-ylmethyl)amino]phenyl}sulfonyl}-2-(1H- pyrrolo[2,3-b]pyridin-5-yloxy)benzamide
Date Designated: 07/01/2020
Orphan Designation: Treatment of Waldenstrom macroglobulinemia
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Ascentage Pharma Group Inc.
700 King Farm Blvd., Suite 510
Rockville , Maryland 20850
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.