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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: osilodrostat
Trade Name: Isturisa
Date Designated: 04/29/2024
Orphan Designation: Treatment of endogenous Cushing's syndrome excluding Cushing's disease
Orphan Designation Status: Designated/Approved
Recordati Rare Diseases Inc.
440 Route 22, Suite 205
Bridgewater, New Jersey 08807
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: osilodrostat
Trade Name: Isturisa
Marketing Approval Date: 04/15/2025
Approved Labeled Indication: treatment of endogenous hypercortisolemia in adults with Cushing's syndrome for whom surgery is not an option or has not been curative
Exclusivity End Date: 04/15/2032 
Exclusivity Protected Indication* :  treatment of endogenous hypercortisolemia in adults with Cushing's syndrome for whom surgery is not an option or has not been curative, excluding patients with Cushing's disease
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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