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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: 09/13/2013
Orphan Designation: Treatment of Cushing's disease
Orphan Designation Status: Designated/Approved
Recordati Rare Diseases, Inc
100 Corporate Drive
Lebanon, New Jersey 08833
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: 03/06/2020
Approved Labeled Indication: ISTURISA is a cortisol synthesis inhibitor indicated for the treatment of adult patients with Cushing¿s disease for whom pituitary surgery is not an option or has not been curative.
Exclusivity End Date: 03/06/2027 
Exclusivity Protected Indication* :  For the treatment of adult patients with Cushing¿s disease for whom pituitary surgery is not an option or has not been curative.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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