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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
Trade Name: Braftovi
Date Designated: 09/08/2021
Orphan Designation: Treatment of BRAF-mutant Non-Small Cell Lung Cancer
Orphan Designation Status: Designated/Approved
Array BioPharma Inc. (a wholly owned subsidiary of Pfizer Inc.)
445 Eastern Point Road
Groton, Connecticut 06340-5146
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: encorafenib
Trade Name: Braftovi
Marketing Approval Date: 10/11/2023
Approved Labeled Indication: in combination with binimetinib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test
Exclusivity End Date: 10/11/2030 
Exclusivity Protected Indication* :  treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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