Indevus Pharmaceuticals has received a non-approvable letter from FDA for Valstar related to its chemistry, manufacturing and controls NDA supplement submitted to the FDA in May 2007. The letter was received following the Company's response to an August 2007 approvable letter. Valstar, a sterile solution of valrubicin for intravesical instillation, 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 acquired Valstar through its acquisition of Valera Pharmaceuticals and after completing the resolution of the impurity issue, submitted a chemistry, manufacturing and controls NDA supplement to the FDA in May 2007.
Bayer HealthCare Pharmaceuticals will discontinue marketing of Viadur (leuprolide acetate implant) based on diminished market demand and growing manufacturing costs, the company said. The decision to discontinue marketing of Viadur is not the result of safety or efficacy issues, Bayer added in a statement. Viadur is indicated to manage the symptoms associated with advanced prostate cancer, including pain, urinary problems and other symptoms typical of the disease. Bayer will fulfill orders until current supplies are depleted, expected by the end of April 2008.