K-V Challenge To FDA's Enforcement Order On Thin Ice: Judge

Law360, Washington (August 7, 2012, 10:30 PM EDT) -- 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.

While K-V claims that the FDA isn't following its traditional enforcement procedures and that it encouraged pharmacies to produce cheaper, compounded versions of Makena's active ingredient — 17-hydroxyprogesterone caproate, or 17-HPC — via a March 2011 press release, U.S. District Judge Amy...
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Case Information

Case Title

K-V PHARMACEUTICAL COMPANY et al v. UNITED STATES FOOD AND DRUG ADMINISTRATION et al


Case Number

1:12-cv-01105

Court

District Of Columbia

Nature of Suit

Other Statutory Actions

Judge

Amy Berman Jackson

Date Filed

July 5, 2012

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