FDA Says K-V Can't Challenge Its Enforcement Decisions

Law360, Washington (July 23, 2012, 1:52 PM EDT) -- K-V Pharmaceutical Co. can't force the U.S. Food and Drug Administration to crack down on cheaper compounded alternatives of the manufacturer's premature birth prevention drug Makena since FDA enforcement decisions aren't eligible for judicial review, the agency told a Washington federal court on Friday.

While the drugmaker claims the FDA is shirking its duties by allowing pharmacies to produce cheaper, individualized versions of Makena's active ingredient — 17-hydroxyprogesterone caproate, or 17-HPC — since it received FDA approval in February 2011, the agency says Makena's orphan drug...
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