Search Orphan Drug Designations and Approvals
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Generic Name: | osilodrostat | ||||||||||||||||
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Trade Name: | Isturisa | ||||||||||||||||
Date Designated: | 09/13/2013 | ||||||||||||||||
Orphan Designation: | Treatment of Cushing's disease | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
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. |
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Marketing approved: |
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1 | Generic Name: | osilodrostat |
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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. | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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