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www.fdanews.com/articles/68096-sonus-tocosol-paclitaxel-gets-orphan-drug-designation-for-bladder-cancer

Sonus' Tocosol Paclitaxel Gets Orphan-Drug Designation for Bladder Cancer

January 28, 2005

Sonus Pharmaceuticals has announced that the FDA has granted an orphan-drug designation to its lead oncology candidate, Tocosol Paclitaxel, for the treatment of nonsuperficial urothelial cancer.

The most common form of urothelial cancer is bladder cancer. The orphan-drug designation adds to the fast-track designation awarded in 2003 by the FDA Division of Oncology Drug Products for the development of Tocosol Paclitaxel for the treatment of metastatic or locally advanced, inoperable transitional cell carcinoma of the urothelium.

Tocosol Paclitaxel is a novel formulation of paclitaxel, a widely prescribed anticancer drug for the treatment of solid tumors.