A Warning Letter sent by the US Food and Drug Administration (FDA) this week offers yet another addition in the long and interesting chapter of KV Pharmaceuticals’ Makena (17-hydroxyprogesterone caproate). In 2011, FDA approved Makena under an orphan drug designation. While the drug had been used by doctors for years to prevent premature births, KV was the first company to bring Makena through clinical testing. Under the terms of FDA’s approval, all other manufacturers would have to take the drug off the market for at least seven years.
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