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District Court Throws Out KV’s Makena Lawsuit Against FDA

In another blow for the bankrupt KV Pharmaceutical, the U.S. District Court for the District of Columbia has dismissed the company’s lawsuit against the FDA. KV challenged the FDA’s failure to take enforcement action against pharmacies compounding its pre-term birth drug Makena (hydroxyprogesterone caproate) and the agency’s failure to block foreign imports of the two active pharmaceutical ingredients used by the compounding pharmacies.
Washington Drug Letter