Oct. 16, 2008 - Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated, global biotechnology company, and Specialised Therapeutics Australia Pty Ltd, today announced that approval has been received from the Therapeutic Goods Administration (TGA) in Australia to market ABRAXANE(R) (nanoparticle albumin-bound paclitaxel) 100 mg powder for injection (suspension) for the treatment of metastatic carcinoma of the breast after failure of anthracycline therapy. The Phase III clinical trial results on which this approval was based demonstrated that ABRAXANE doubled the response rate and significantly prolonged progression-free survival and overall survival versus Taxol(R) in the approved indication. With this approval, ABRAXANE is now cleared for marketing in 36 countries.
The details can be read here.
No comments:
Post a Comment