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Indevus gets approvable letter
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Indevus got a preliminary FDA nod on Valstar, its bladder cancer therapy. The drug had been taken off the market in 2002 because of "impurities" in the original formula; since then, the company has revamped its process. In May, Indevus submitted a chemistry, manufacturing, and controls supplement to the agency.
The FDA's new approvable letter blesses the chemistry portion of the app and asks for more info about manufacturing. Company officials say they'll answer within two months, and that they expect to re-introduce VALSTAR late this year or early next.Â
- check out the release
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