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Drug Development
New drug application for sorafenib accepted for U.S. FDA review
October 23rd, 2005
Bayer Pharmaceuticals Corp. (BAY) and Onyx Pharmaceuticals, Inc., (ONXX) announced that the New Drug Application (NDA) for sorafenib (BAY 43-9006) for patients with advanced renal cell carcinoma (RCC), or kidney cancer, has been accepted for review and granted Priority Review status by the U.S. Food and Drug Administration (FDA). Priority Review designation expedites the approval process for investigational agents that address unmet medical needs. Based on this designation, the FDA reviews the application with a goal of taking action within 6 months of the date on which they received the NDA. "This, along with our recent European filing, puts us...
Source: Medical Letter on the CDC & FDA (2005-10-23)
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