K-V Pharmaceutical Files for Bankruptcy

K-V Pharmaceutical Co., a provider of women’s health-care products, filed for bankruptcy after it said lax federal enforcement and state Medicaid restrictions prevented it from attaining the “full value” of a medicine intended to help pregnant women avoid premature births.

The drug company, which sought court protection along with several subsidiaries, listed debt of $728 million and assets of $237 million in a Chapter 11 petition filed today in U.S. Bankruptcy Court in Manhattan. Based in Bridgeton, Missouri, K-V said it will keep operating as it seeks to reorganize.

“The company has been unable to realize the full value of its most important product, Makena, because of a lack of enforcement of the orphan drug marketing exclusivity granted to K-V for Makena by the Food and Drug Administration,” Greg Divis, chief executive officer of K-V, said in a statement. “The lack of enforcement has also led certain state Medicaid agencies to impose barriers to access to Makena on low-income pregnant women at high risk for recurrent preterm birth, despite those states’ legal obligation to cover FDA-approved drugs.”

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