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 BRAFV600E mutation as detected by an FDA-approved test.
Development History and FDA Approval Process for Zelboraf
|Aug 17, 2011||FDA Approves Zelboraf and Companion Diagnostic Test for Late-Stage Skin Cancer|
|May 11, 2011||New Drug Applications Submitted in the United States and Europe for Vemurafenib in Advanced Skin Cancer|
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