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Developer of bladder cancer drug receives non-approvable letter

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Indevus Pharmaceuticals, Inc. has received a non-approvable letter from FDA for valrubicin for intravesical instillation (Valstar), related to the drug’s chemistry, manufacturing, and controls new drug application supplement submitted to the FDA last May. Valrubicin is indicated for bacillus Calmette-Guerin-refractory carcinoma in situ of the bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality.

Indevus Pharmaceuticals, Inc. has received a non-approvable letter from FDA for valrubicin for intravesical instillation (Valstar), related to the drug’s chemistry, manufacturing, and controls new drug application supplement submitted to the FDA last May. Valrubicin is indicated for bacillus Calmette-Guerin-refractory carcinoma in situ of the bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality.

Indevus said issues that caused the 2002 withdrawal of the product from the market have been satisfactorily resolved. However, during a recent FDA pre-approval inspection of the company’s third-party manufacturing facility for valrubicin, 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.

“We have been in direct communication with the FDA, and they have committed to working closely with us and our manufacturer to resolve the open cGMP issues in an expeditious manner,” said Glenn L. Cooper, MD, of Indevus. “They appreciate the need and desire to return Valstar, currently on the FDA Drug Shortages List, to the market as quickly as possible.”

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