Indevus Pharmaceuticals suffered another setback relating to the reintroduction of its bladder cancer treatment Valstar as manufacturing issues are preventing approval of the product.
Valstar (valrubicin), which is a sterile injection, was withdrawn from the market in 2002 because of impurities in its original formulation. After these issues were resolved, the firm resubmitted the chemistry, manufacturing and controls section of its new drug application in May 2007.
The FDA followed up with an approvable letter in August 2007, requesting clarification of manufacturing validation protocols and additional data on the production process.
The most recent FDA action, a Dec. 19, 2007, nonapprovable letter, concerned a third-party manufacturing facility making the product under contract to Indevus.
The company said that the agency was concerned with the physical plant facilities of San Diego-based contract manufacturer PrimaPharm. When asked if it was considering retaining another firm to produce the drug as a backup, Indevus said it was committed to resolving the issues at PrimaPharm.
Valstar, which is on the FDA’s drug shortage list, is the only agency-approved drug to treat carcinoma in situ of the urinary bladder in the bacille Calmette-Guerin refractory setting. Indevus said it hopes to reintroduce the drug by the end of the first quarter of the year.