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Nexavar Approval History

FDA Approved: Yes (First approved December 20, 2005)
Brand name: Nexavar
Generic name: sorafenib
Dosage form: Tablets
Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Renal Cell Carcinoma, Hepatocellular Carcinoma, Thyroid Cancer

Nexavar (sorafenib) is an oral multi-kinase inhibitor indicated for the treatment of hepatocellular carcinoma, renal cell carcinoma, and thyroid carcinoma.

Development History and FDA Approval Process 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
Nov 19, 2007Approval FDA Approves Nexavar (sorafenib) for Unresectable Hepatocellular Carcinoma
Aug 20, 2007Nexavar Granted FDA Priority Review for Treatment of Liver Cancer
Dec 20, 2005Approval FDA Approves Nexavar (sorafenib) 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

Further information

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