FDA Encouraged Illegal Compounding, K-V Tells DC Circ.

Law360, Washington (December 13, 2013, 2:51 PM ET) -- Bankrupt drugmaker K-V Pharmaceutical Co. on Friday urged a D.C. Circuit panel to prevent the U.S. Food and Drug Administration from allowing unapproved compounding ingredients into the country that are used to create products that compete with its prenatal drug Makena, alleging the agency has encouraged unlawful behavior.

K-V launched a two-prong attack on the FDA's refusal to prevent unapproved versions of its orphan drug from hitting the market, asking the court to prevent the compounds' Chinese-imported active pharmaceutical ingredient from entering the country and to...
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