Zelboraf Approval History

  • FDA approved: Yes (First approved August 17th, 2011)
  • Brand name: Zelboraf
  • Generic name: vemurafenib
  • Company: Genentech, Inc.
  • Treatment for: Melanoma, Metastatic

Zelboraf (vemurafenib) is a kinase inhibitor indicated for the treatment of patients with metastatic melanoma with BRAFV600E mutation as detected by an FDA-approved test.

FDA Approval History for Zelboraf

DateArticle
Aug 17, 2011Approval FDA Approves Zelboraf and Companion Diagnostic Test for Late-Stage Skin Cancer
May 11, 2011New Drug Applications Submitted in the United States and Europe for Vemurafenib in Advanced Skin Cancer

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