Valstar (valrubicin, from Indevus Pharmaceuticals), an anthracycline derivative, has received approval from the FDA for its supplemental New Drug Application (sNDA). Previously, Valstar was withdrawn from the U.S. market and placed on the FDA drug shortages list due to impurity issues arising during manufacturing. This present approval is based on the resolution of the manufacturing issues that caused the 2002 market withdrawal.
Valstar is indicated for intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients from whom immediate cystectomy would be associated with unacceptable morbidity or mortality. It will be available in the second half of 2009.
For more information call (800) 462-ENDO or visit www.valstarsolution.com.