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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: rociletinib
Date Designated: 05/14/2013
Orphan Designation: Treatment of non-small cell lung cancer and mutations in the epidermal growth factor receptor
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Clovis Oncology, Inc.
5500 Flatiron Parkway
Suite 100
Boulder, Colorado 80301
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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