The second coming of valrubicin
Previously approved in 1998 to treat bladder cancer and discontinued in 2002 by then-manufacturer Anthra Pharmaceuticals, valrubicin (Valstar) may make another debut, this time from Valera Pharmaceuticals. Valera has just completed its acquisition of the NDA for the drug, and the company said it hopes to have the product available by the end of 2006.
The second coming of valrubicin
Previously approved in 1998 to treat bladder cancer and discontinued in 2002 by then-manufacturer Anthra Pharmaceuticals, valrubicin (Valstar) may make another debut, this time from Valera Pharmaceuticals. Valera has just completed its acquisition of the NDA for the drug, and the company said it hopes to have the product available by the end of 2006. Valrubicin is an anthracycline derivative used as an intravesical therapy of BCG-refractory carcinoma in situ of the urinary bladder. Valera said it expects to sell the treatment directly to urologists to be administered as an office procedure.
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FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
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