Drug Development

Nexavar (sorafenib tosylate) tablets chosen as trade name for investigational cancer treatment

Published in Medical Letter on the CDC and FDA, December 4th, 2005

Bayer Pharmaceuticals Corp. (BAY) and Onyx Pharmaceuticals, Inc., (ONXX) announced the selection of Nexavar (sorafenib tosylate) Tablets as the global trade name for sorafenib, the oral investigational drug under U.S. Food and Drug Administration (FDA) review for the treatment of advanced renal cell carcinoma (RCC), or kidney cancer.

Bayer and Onyx filed a New Drug Application (NDA) in July 2005 requesting approval in advanced renal cell cancer by the FDA. Subsequently, the FDA granted the Nexavar filing priority review status, which means the FDA intends to make a determination within 6 months of when they received the NDA.

Additionally in September...

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Source: Medical Letter on the CDC and FDA (2005-12-04)

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