Nexavar Approval History

  • FDA approved: Yes (First approved December 20th, 2005)
  • Brand name: Nexavar
  • Generic name: sorafenib
  • Company: Bayer Pharmaceuticals Corporation/Onyx Pharmaceuticals, Inc.
  • Treatment for: Renal Cell Carcinoma

Nexavar (sorafenib) is an oral multi-kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma, liver cancer, and thyroid cancer.

FDA Approval History for Nexavar

DateArticle
Nov 22, 2013Approval FDA Approves Nexavar to Treat Metastatic Differentiated Thyroid Cancer
Jul  1, 2013Bayer and Onyx Pharmaceuticals Announce Submission of FDA and EMA Applications for Nexavar (sorafenib) for the Treatment of Radioactive Iodine-Refractory Differentiated Thyroid Cancer
Aug 20, 2007Nexavar Granted FDA Priority Review for Treatment of Liver Cancer
Dec 20, 2005Approval Nexavar Bayer Pharmaceuticals Corporation/Onyx Pharmaceuticals, Inc. - Treatment for Advanced Renal Cell Carcinoma
Sep 14, 2005Bayer and Onyx Announce FDA Acceptance of New Drug Application for Sorafenib for Individuals with Advanced Renal Cell Carcinoma
Jul 11, 2005Bayer and Onyx Complete Filing of New Drug Application for Sorafenib for Individuals with Advanced Renal Cell Carcinoma

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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