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When a product has marketing exclusivity, competing versions are barred from the market for up to seven years. K-V has said the quality of Makena is more consistent than versions compounded by pharmacies. The company said Monday that state Medicaid agencies are stopping low-income pregnant women from getting Makena even though those agencies are obliged to cover drugs that have FDA approval.
The FDA told K-V to stop making some time-release drugs in 2008, but K-V did not comply. The FDA later seized millions of dollars' worth of K-V products. The company stopped all manufacturing and shipping in January 2009 after a series of product recalls. In February 2010 K-V pleaded guilty to charges it failed to inform regulators about manufacturing problems that caused some of its pills to be too large, increasing the risk of accidental overdoses. It agreed to pay $27.6 million to settle government investigations.
K-V also closed its Ethex generic-drug business. It later created a new generic unit but sold the division in 2011.
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