Wednesday, January 8, 2014

Updated: Jan 8, 2014, 7:04am CST K-V still battling with FDA


Staff St. Louis Business Journal
A lawsuit filed by KV Pharmaceutical Co. against the U.S. Food and Drug Administration has been revived after a federal appeals court ordered a lower-court judge to reconsider the dismissal of the suit.
KV filed the suit in July 2012, alleging that the FDA did not crack down on compounded versions of KV's premature birth drug Makena. The suit alleged the FDA’s actions led to “unlawful competition” for the drug and caused KV “irreparable harm.”
In September 2012 Judge Amy Berman Jackson of the U.S. District Court of the District of Columbia dismissed the lawsuit, ruling the court can not direct and oversee the FDA’s enforcement activities.

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