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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: vemurafenib
Trade Name: Zelboraf
Date Designated: 12/20/2010
Orphan Designation: Treatment of patients with IIb to Stage IV melanoma positive for the BRAF(v600) mutation
Orphan Designation Status: Designated/Approved
Hoffmann-La Roche, Inc.
340 Kingsland Street
Nutley, New Jersey 07110
United States

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

Marketing approved:

1 Generic Name: vemurafenib
Trade Name: Zelboraf
Marketing Approval Date: 08/17/2011
Approved Labeled Indication: Treatment of unresectable or metastatic melanoma with the BRAFV600E mutation as detected by an FDA-approved test.
Exclusivity End Date: 08/17/2018 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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