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Zelboraf Approval History

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

Zelboraf (vemurafenib) is a kinase inhibitor indicated for the treatment of patients with metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test, and for the treatment of patients with Erdheim-Chester Disease with BRAF V600 mutation.

Development History and FDA Approval Process for Zelboraf

Nov  6, 2017Approval FDA Approves Zelboraf (vemurafenib) for Erdheim-Chester Disease with BRAF V600 Mutation
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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