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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Epirubicin
Trade Name: Ellence
Date Designated: 09/14/1999
Orphan Designation: Treatment of breast cancer.
Orphan Designation Status: Designated/Approved
Pharmacia & Upjohn Company
0634-298-113
7000 Portage Rd.
Kalamazoo, Michigan 49001
United States

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

Marketing approved:

1 Generic Name: Epirubicin
Trade Name: Ellence
Marketing Approval Date: 09/15/1999
Approved Labeled Indication: Component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer.
Exclusivity End Date: 09/15/2006 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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