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KV Pharmaceutical Wins a Makena Ruling in Georgia


8/13/2012 6:54:31 AM

In a rare victory for KV Pharmaceutical, a federal judge late last week ruled that the Georgia Medicaid program must cover its Makena treatment for premature births. The move comes shortly after the drugmaker filed a lawsuit claiming that previous coverage restrictions by the Georgia Department of Community Health contributed to its financial problems and reflected the fallout of a larger dispute with the FDA over the medication. As we reported previously, KV Pharma is trying to salvage its Makena franchise, which was projected to become a big moneymaker after the FDA approved the treatment early last year under the Orphan Drug Act. Shortly afterwards, though, both the drugmaker and the agency came under fire because the price was set at $1,500, compared with $10 to $20 a week for compounded versions of a medication that has been used for decades.

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