FDA Approval Activities for this Drug…

Valstar (valrubicin) Sterile Solution for Intravesical Instillation, 5 mL, Single-Use Vials (40 mg/mL) Anthra NDA 20-892 9/25/98 9/28/98 9/28/98 7/8/99 Valstar Indication: intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality.

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