Indevus Receives Approvable Letter From FDA for Valstar

Indevus Pharmaceuticals said it has received an approvable letter from the FDA for Valstar, the only product approved by the FDA for therapy of bacillus Calmette-Guerin-refractory carcinoma in situ of the urinary bladder.

Valstar was removed from the market in 2002 due to impurities in the original formulation and was placed on the FDA Drug Shortages List.

Indevus said it solved the impurity issue and submitted a chemistry, manufacturing and controls new drug application supplement to the FDA in May. The FDA approvable letter was in response to this chemistry supplement.

According to the company, the FDA asked for clarification regarding manufacturing validation protocols and for additional data on the manufacturing process.