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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: 05/12/1998
Orphan Designation: Reduction of the incidence of moderate to severe xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer.
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: 06/24/1999
Approved Labeled Indication: Reduction of the incidence of moderate to severe xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer, where the radiation port includes a substantial portion of the parotid glands.
Exclusivity End Date: 06/24/2006 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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