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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: raloxifene
Trade Name: Evista
Date Designated: 07/14/2005
Orphan Designation: Reduction of the risk of breast cancer in postmenopausal women
Orphan Designation Status: Designated/Approved
Eli Lilly and Company
Lilly Corporate Center
Drop Code 1853
Indianapolis, Indiana 46285
United States

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

Marketing approved:

1 Generic Name: raloxifene
Trade Name: Evista
Marketing Approval Date: 09/13/2007
Approved Labeled Indication: Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and reduction in risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer
Exclusivity End Date: 09/13/2014 
Exclusivity Protected Indication* :  

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