Indevus Pharmaceuticals, Inc. has submitted a Supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) seeking approval to reintroduce Valstar in the United States. Valstar was originally approved by the FDA in 1998 and is currently on the FDA Drug Shortages List.
Valstar was removed from the market in 2002 due to manufacturing issues involving the stability of an excipient (an inactive ingredient). The company believes the stability issues have been resolved through the development of an improved manufacturing process.
"The submission of the Valstar s NDA is an important milestone for Indevus," said Glenn L. Cooper, M.D., chief executive officer and chairman of Indevus. "valstar is the only approved drug for the treatment of BCG- refractory bladder cancer in patients who are not candidates for surgical bladder removal. We are hopeful that we will be able to reintroduce Valstar to the marketplace by the end of 2007 and provide physicians and patients with a much needed treatment option. In addition, we believe Valstar has the potential to be effective in other clinical indications and we plan to begin exploring additional development opportunities that may result in expanding the overall VALSTAR market potential."
Valstar is a sterile solution for intravesical (bladder) instillation of valrubicin, a chemotherapeutic anthracycline derivative. Valstar is the only product currently approved by the FDA for therapy of Bacillus Calmette-Guerin (BCG) - refractory carcinoma in situ (CIS) of the urinary bladder. Valstar is used in BCG-refractory bladder cancer patients who are not candidates for surgical bladder removal (cystectomy).
Indevus Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the acquisition, development and commercialization of products to treat conditions in urology and endocrinology.