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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: binimetinib
Date Designated: 11/19/2013
Orphan Designation: Treatment Stage IIB-IV melanoma.
Orphan Designation Status: Designated/Withdrawn
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Array BioPharma Inc., a wholly-owned subsidiary of Pfizer 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.