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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Exemestane
Trade Name: Aromasin
Date Designated: 09/19/1991
Orphan Designation: Treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy.
Orphan Designation Status: Designated/Approved
Pharmacia & Upjohn
7000 Portage Road
Mail Stop: 0636-298-113
Kalamazoo, Michigan 49001
United States

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

Marketing approved:

1 Generic Name: Exemestane
Trade Name: Aromasin
Marketing Approval Date: 10/21/1999
Approved Labeled Indication: Treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy.
Exclusivity End Date: 10/21/2006 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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