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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Altretamine
Trade Name: Hexalen
Date Designated: 02/09/1984
Orphan Designation: Treatment of advanced adenocarcinoma of the ovary.
Orphan Designation Status: Designated/Approved
Medimmune Oncology, Inc.
One Tower Bridge
100 Front Street, Suite 400
West Conshohocken, Pennsylvania 19428
United States

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

Marketing approved:

1 Generic Name: Altretamine
Trade Name: Hexalen
Marketing Approval Date: 12/26/1990
Approved Labeled Indication: Single agent palliative treatment of patients with persistent or recurrent ovarian cancer following first-line therapy with a cisplatin and/or alkylating agent based combination.
Exclusivity End Date: 12/26/1997 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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