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news.Indevus Pharmaceuticals has received a non-approvable letter from the FDA for Valstar related to its chemistry, manufacturing and controls new drug application supplement submitted to the FDA in May 2007. The letter was received following the company's response to an August 2007 approvable letter.
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The Valstar-specific issues that caused the 2002 withdrawal of the product from the market have been reportedly resolved. However, during a recent FDA pre-approval inspection of the company’s third-party manufacturing facility for Valstar, deficiencies were identified that require resolution prior to approval.
The company believes that successfully addressing the deficiencies at the manufacturing plant is the only remaining item for product approval. Upon resolution, which the company expects to occur within several months, the company will respond to the FDA and request re-inspection of the facility.
Valstar is indicated for intravesical therapy of bacillus Calmette-Guerin (BCG)-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality.