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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Amifostine
Trade Name: Ethyol
Date Designated: 05/30/1990
Orphan Designation: For use as a chemoprotective agent for cisplatin in the treatment of advanced ovarian carcinoma.
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: Amifostine
Trade Name: Ethyol
Marketing Approval Date: 12/08/1995
Approved Labeled Indication: To reduce the cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer.
Exclusivity End Date: 12/08/2002 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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