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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-{2,6-Dichloro-3-[(2,2-dimethyl-propionylamino)-methyl]-phenylamino}-6-(2,2-difluoroethoxy)-1-methyl-1H-benzoimidazole-5-carboxylic acid (trans-4-trifluoromethylcyclohexyl)-amide, hydrogensulfate
Date Designated: 02/28/2022
Orphan Designation: Treatment for Systemic Sclerosis
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 05/09/2024
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Gesynta Pharma AB
Fogdevreten 2A
Solna 171 65
Sweden

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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