Indevus Pharmaceuticals, Inc., of Lexington, Mass., has received a non-approvable letter from the FDA for Valstar (valrubicin solution), the only approved product for therapy of bacillus Calmette-Guérin-refractory carcinoma in situ of the urinary bladder.
The letter was received following the company’s response to an earlier approvable letter (FDA News, October 2007). Indevus stated that while the Valstar-specific issues that caused the 2002 withdrawal of the product from the market have been satisfactorily resolved, deficiencies at a third-party manufacturing facility for the drug were identified that require resolution prior to approval.
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