The FDA has handed an approvable letter to Indevus Pharmaceuticals for VALSTAR, a sterile solution of valrubicin for intravesical instillation for the treatment of bacillus Calmette-Guerin-refractory carcinoma in situ of the urinary bladder. In 2002, Valstar was pulled from the market due to formulation impurities, which Indevus has since corrected. In the approvable letter, the FDA asked for clarification regarding manufacturing validation protocols and for additional data on the manufacturing process.
- see the Indevus release for more