Indevus Pharmaceuticals, Inc., of Lexington, Mass., announced that it has received an approvable letter for Valstar (valrubicin solution), the only FDA-approved product for therapy of bacillus Calmette-Guérin-refractory carcinoma in situ of the urinary bladder.
The drug was removed from the market five years ago because of impurities in the original formulation and was placed on the agency’s Drug Shortages List. Indevus submitted a chemistry, manufacturing, and controls (CMC) NDA supplement last May, and the approvable letter was in response to this CMC supplement.
In the letter, the FDA asked for clarification regarding manufacturing validation protocols and for more data on the manufacturing process. “The FDA requests in the approvable letter are easily addressable with existing data and the completion of a few brief process-related investigations,” stated Glenn L. Cooper, MD, chairman and chief executive officer of Indevus.
“We expect to supply the FDA with a complete response within the next two months. We remain on track for a late 2007 or early 2008 re-introduction.”