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K-V PHARMACEUTICAL COMPANY et al v. UNITED STATES FOOD AND DRUG ADMINISTRATION et al
Case Number:
1:12-cv-01105
Court:
Nature of Suit:
Judge:
Firms
Companies
Government Agencies
Sectors & Industries:
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September 06, 2012
K-V Can't Challenge FDA Enforcement Decisions, Judge Rules
A Washington federal judge on Thursday dismissed K-V Pharmaceutical Co.'s attempt to force the U.S. Food and Drug Administration to block pharmacies from producing cheaper compounded versions of K-V's preterm-birth prevention drug Makena, saying the agency's enforcement actions are not subject to judicial review.
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August 07, 2012
K-V Challenge To FDA's Enforcement Order On Thin Ice: Judge
A Washington federal judge indicated Tuesday that forcing the U.S. Food and Drug Administration to block pharmacies from producing cheaper compounded versions of K-V Pharmaceutical Co.'s preterm birth prevention drug Makena is an unlikely action, as the agency's enforcement discretion cannot be judicially reviewed.
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July 23, 2012
FDA Says K-V Can't Challenge Its Enforcement Decisions
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.
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July 05, 2012
K-V Pharma Sues FDA Over Exclusivity For Preterm Birth Drug
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.