(RTTNews.com) - AVEO Oncology ( AVEO ) and Astellas Pharma Global Development Inc., a U.S. subsidiary of Tokyo-based Astellas Pharma Inc., announced Wednesday that the U.S. Food and Drug Administration's or FDA Oncologic Drugs Advisory Committee or ODAC will review the company's New Drug Application or NDA for tivozanib for the treatment of patients with advanced renal cell carcinoma or RCC during the morning session of its meeting on May 2, 2013.
ODAC reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer, and makes recommendations to the Commissioner of Food and Drugs. According to the timelines established by the Prescription Drug User Fee Act or PDUFA, the review of the NDA is expected to be complete by July 28, 2013.
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Source: RTT News