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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: mifepristone
Trade Name: Korlym
Date Designated: 07/05/2007
Orphan Designation: Treatment of the clinical manifestations of endogenous Cushing's syndrone
Orphan Designation Status: Designated/Approved
Corcept Therapeutics, Inc.
149 Commonwealth Drive
Menlo Park, California 94025
United States

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

Marketing approved:

1 Generic Name: mifepristone
Trade Name: Korlym
Marketing Approval Date: 02/17/2012
Approved Labeled Indication: for the control of hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery.
Exclusivity End Date: 02/17/2019 
Exclusivity Protected Indication* :  

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.