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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 + binimetinib
Trade Name:  
Date Designated:  11/19/2013
Orphan Designation:  Treatment of Stage IIB-IV melanoma positive for the BRAF mutation.
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  06/27/2018 
Approved Labeled Indication:  BRAFTOVI™ is indicated, in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test
Exclusivity End Date:    06/27/2025 
Exclusivity Protected Indication* :  BRAFTOVI™ (encorafenib) and MEKTOVI® (binimetinib) indicated, in combination, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.
Array BioPharma, Inc.
100 Cambridgepark Drive
Suite 505
Cambridge, Massachusetts 02140
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
 
Generic Name:  encorafenib + binimetinib
Trade Name:  
Date Designated:  11/19/2013
Orphan Designation:  Treatment of Stage IIB-IV melanoma positive for the BRAF mutation.
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  06/27/2018 
Approved Labeled Indication:  MEKTOVI® is indicated, in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test
Exclusivity End Date:    06/27/2025 
Exclusivity Protected Indication* :  BRAFTOVI™ (encorafenib) and MEKTOVI® (binimetinib) indicated, in combination, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.
Array BioPharma, Inc.
100 Cambridgepark Drive
Suite 505
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.
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