Company slated to re-introduce bladder cancer drug
Indevus Pharmaceuticals, Inc. has received an approvable letter from the FDA for valrubicin (Valstar), indicated for intravesical therapy of bacillus Calmette-Guerin (BCG)-refractory carcinoma in situ of the bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality.
Indevus Pharmaceuticals, Inc. has received an approvable letter from the FDA for valrubicin (Valstar), indicated for intravesical therapy of bacillus Calmette-Guerin (BCG)-refractory carcinoma in situ of the bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality.
Valrubicin 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 new drug application supplement to the FDA in May 2007. The FDA approvable letter was issued in response to this supplement.
In the approvable letter, the FDA asked for clarification regarding manufacturing validation protocols and for additional data on the manufacturing process. An Indevus spokesman said the company is preparing a response to the letter, and expects to re-introduce the drug by early 2008.
