K-V Bankruptcy May Hurt FDA's Unapproved Drug Initiative

Law360, New York (August 8, 2012, 5:40 PM EDT) -- K-V Pharmaceutical Co. claims a U.S. Food and Drug Administration decision to allow cheap compounded drugs to compete with its newly approved brand-name drug drove it to bankruptcy, a move experts say may undermine a key FDA initiative to get unapproved drugs reviewed and regulated.

In its Chapter 11 bankruptcy filing Saturday, K-V blamed its financial troubles on the FDA for undermining its exclusivity on Makena, a drug meant to prevent preterm births. Makena was approved in February 2011, as part of the FDA's efforts to...
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