Indevus Pharmaceuticals submits supplemental NDA for VALSTAR

Apr 20 2007

Indevus Pharmaceuticals has announced that it has submitted a Supplemental New Drug Application (sNDA) to the U.S. 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 sNDA 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."