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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Temsirolimus
Trade Name: Torisel
Date Designated: 12/16/2004
Orphan Designation: Treatment of renal cell carcinoma
Orphan Designation Status: Designated/Approved
Wyeth Pharmaceuticals, Inc.
P. O. Box 8299
Phildelphia, Pennsylvania 19101
United States

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

Marketing approved:

1 Generic Name: Temsirolimus
Trade Name: Torisel
Marketing Approval Date: 05/30/2007
Approved Labeled Indication: Treatment of advanced renal cell carcinoma
Exclusivity End Date: 05/30/2014 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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