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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Toremifene
Trade Name: Fareston
Date Designated: 09/19/1991
Orphan Designation: Hormonal therapy of metastatic carcinoma of the breast.
Orphan Designation Status: Designated/Approved
Orion Corporation
Orionintie 1
Espoo
Finland

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

Marketing approved:

1 Generic Name: Toremifene
Trade Name: Fareston
Marketing Approval Date: 05/29/1997
Approved Labeled Indication: Treatment of metastatic breast cancer in postmenopausal women with estrogen positive or receptor unknown tumors.
Exclusivity End Date: 05/29/2004 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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