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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: levoketoconazole
Trade Name: Recorlev
Date Designated: 03/09/2012
Orphan Designation: Treatment of endogenous Cushing's syndrome
Orphan Designation Status: Designated/Approved
Strongbridge Dublin Limited
Suite 206, Fitzwilliam Hall
Dublin 2 D02 T292
Ireland

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

Marketing approved:

1 Generic Name: levoketoconazole
Trade Name: Recorlev
Marketing Approval Date: 12/30/2021
Approved Labeled Indication: Treatment of endogenous hypercortisolemia in adult patients with Cushing's syndrome for whom surgery is not an option or has not been curative
Exclusivity End Date: 12/30/2028 
Exclusivity Protected Indication* :  Treatment of endogenous hypercortisolemia in adult patients with Cushing's syndrome for whom 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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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