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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: 08/02/2016
Orphan Designation: Treatment of Erdheim-Chester Disease
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: vemurafenib
Trade Name: Zelboraf
Marketing Approval Date: 11/06/2017
Approved Labeled Indication: Treatment of patients with Erdheim-Chester Disease with BRAF V600 mutation
Exclusivity End Date: 11/06/2024 
Exclusivity Protected Indication* :  Treatment of patients with Erdheim-Chester Disease with BRAF V600 mutation
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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