K-V Pharma Sues FDA Over Exclusivity For Preterm Birth Drug

Law360, New York (July 5, 2012, 6:11 PM EDT) -- K-V Pharmaceutical Co. and its subsidiary on Thursday accused the U.S. Food and Drug Administration and the U.S. Department of Health and Human Services of wrongfully pitting its premature birth prevention drug Makena against compounded drugs that allegedly do not meet FDA's safety standards.

In a complaint filed in Washington, D.C., federal court, the St. Louis-based drugmaker claimed that it had received FDA approval for Makena in February 2011 and was granted a seven-year exclusivity period under the Orphan Drug Act, which governs the development of...
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