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KV Pharmaceutical Loses Lawsuit Against FDA Over Makena


9/7/2012 6:52:13 AM

A federal judge has tossed a lawsuit filed two months ago by KV Pharmaceutical that claimed the FDA abdicated its responsibility to prevent some compounding pharmacies from offering lower-cost versions of its controversial Makena treatment for premature births. The decision, which could still be appealed, is the latest blow to the drugmaker and its fading hopes to build Makena into a blockbuster medication that will captivate investors. In her ruling, US District Court Judge Amy Berman Jackson found that the FDA appropriately exercised its discretion in whether to pursue enforcement actions against compounders. She also ruled that the agency clearly conveyed the circumstances under which such actions may be taken and when compounding was permitted without violating the law. In effect, she decided that KV failed to bring any appropriate claims.

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