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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
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* :  
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.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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