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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: (8'-hydroxy-6'-oxo-3'-phenyl-6'H-spiro[cyclopentyl-1,5'-indolazine]-7'-carbonyl) glycine
Date Designated: 10/24/2024
Orphan Designation: treatment of sickle cell disease
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
KIND Pharmaceuticals LLC
303 Twin Dolphin Dr.
Suite 600
Redwood City, California 94065-1422
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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