This excerpt taken from the ABII 8-K filed Apr 1, 2008.
Global Approval Status of ABRAXANE®
ABRAXANE is currently approved for marketing in the United States, Canada, India and the European Union. In January 2008, Abraxis received approval from the EU Commission to market ABRAXANE for metastatic breast cancer based on clinical trial data that demonstrated ABRAXANE had significant superiority in the clinical endpoints of response rate, progression free survival and survival when compared with Taxol® in metastatic breast cancer in the second-line setting. ABRAXANE is now approved for commercialization in a total 33 countries.
The company recently announced that its partner, Taiho Pharmaceutical Co., Ltd., has filed a Japanese New Drug Application with the Ministry of Health, Labour and Welfare in Japan to market ABRAXANE for the treatment of breast cancer. The submission in Japan includes four clinical studies that were part of the original New Drug Application in the United States.
Abraxis BioScience, Inc.
2007 Fourth Quarter/Full Year Financial Results
ABRAXANE also is under active review in Australia, Russia, Korea and China by their respective regulatory agencies. The company anticipates approval in Korea and China in the second quarter of 2008, and in Russia and Australia in late 2008.