Indevus Receives Nonapprovable Letter for Valstar

The FDA issued a nonapprovable letter for Indevus Pharmaceuticals’ Valstar, a treatment for bacillus Calmette-Guerin-refractory carcinoma in situ of the urinary bladder.

The letter is related to its chemistry, manufacturing and controls new drug application supplement submitted in May and was received following the company’s response to an August approvable letter.

According to the FDA, the issues that caused the 2002 withdrawal of the product from the market have been resolved. However, during a recent pre-approval inspection of the company’s third-party manufacturing facility for Valstar, deficiencies were identified that require resolution prior to approval.

Indevus said it expects to resolve these issues shortly.