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November 9, 2011
KV Pharmaceutical's Latest Makena Move
Remember the Makena story from earlier this year? That's the progesterone ester whose price was raised (and how) after FDA approval by its manufacturer, KV Pharmaceuticals. (Here's the whole history). When last heard from, the FDA had sent out a letter to compounding pharmacies who were providing the drug at lower cost, saying that they were not intending to take action against them (an unusual move, to be sure).
Now KV has made their next move. According to this FDA statement, the company has provided the agency with data on a number of samples of the drug, claiming variable purity and potency in the compounded products. The FDA is looking over KV's data, and is conducting their own investigation into this as well. For now, they're reminding people that "greater assurance of safety and effectiveness is generally provided by the approved product than by a compounded product". But they're not taking any more action, for now. We'll probably be hearing more about this. . .
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