Search Orphan Drug Designations and Approvals
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Generic Name: | encorafenib | ||||||||||||||||
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Trade Name: | Braftovi | ||||||||||||||||
Date Designated: | 09/08/2021 | ||||||||||||||||
Orphan Designation: | Treatment of BRAF-mutant Non-Small Cell Lung Cancer | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
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. |
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Marketing approved: |
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1 | Generic Name: | encorafenib |
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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 | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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