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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  encorafenib
Date Designated:  11/19/2013
Orphan Designation:  Treatment of Stage IIB-IV melanoma positive for BRAF mutation
Orphan Designation Status:  Designated
FDA Orphan Approval Status:  Not FDA Approved for Orphan Indication
Array BioPharma, Inc.
125 Cambridge Park Drive
Suite 301
Cambridge, Massachusetts 02140
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.