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AVEO, Astellas Announce FDA Advisory Committee to Review NDA for Tivozanib on May 2, 2013

AVEO Oncology (NASDAQ: AVEO) and Astellas Pharma Global Development,
Inc., a U.S. subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo:
4503), today announced that the U.S. Food and Drug Administration's
(FDA) Oncologic Drugs Advisory Committee (ODAC) will review the
company's New Drug Application (NDA) for tivozanib for the treatment of
patients with advanced renal cell carcinoma (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 (PDUFA), the
review of the NDA

See full press release

Posted-In: News Guidance Contracts Management Global

 

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