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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: 2,5,6,11,12,13-Hexahydro-2-methyl-11-(2-methylpropyl)-8-(2-pyrimidinylamino)-4H-indazolo[5,4-c]pyrrolo[3,4-c]carbazol-4-one mono(4-methylbenzenesulfonate)
Date Designated: 03/27/2023
Orphan Designation: Treatment of pancreatic cancer
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Esanik Therapeutics, Inc.
2 W. Liberty Blvd., Suite 110
Malvern, Pennsylvania 19355
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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