August 21, 2007
Indevus Pharmaceuticals has received an approvable letter from the FDA for Valstar, a sterile solution of valrubicin for intravesical instillation. Valstar is the only product approved by the FDA for therapy of bacillus Calmette-Guerin (BCG)-refractory carcinoma in situ (CIS) 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 solved the impurity issue and submitted a chemistry, manufacturing and controls (CMC) NDA supplement to the FDA in May 2007. The FDA approvable letter was in response to this chemistry supplement.