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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: bevacizumab
Trade Name: Avastin
Date Designated: 11/06/2003
Orphan Designation: Treatment of renal cell carcinoma
Orphan Designation Status: Designated/Approved
Genentech, Inc.
1 DNA Way
South San Francisco, California 94080
United States

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

Marketing approved:

1 Generic Name: bevacizumab
Trade Name: Avastin
Marketing Approval Date: 07/31/2009
Approved Labeled Indication: Treatment of renal cell carcinoma in combination with interferon alfa
Exclusivity End Date: 07/31/2016 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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