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United States Seventh Circuit


US v. Genendo Pharm., N.V., 05-4608

Seizure of a pharmaceutical import and permanent injunction against further importation are affirmed where the packaging of the imported drug did not match the requirements listed in the drug's New Drug Approval issued by the FDA and the FDA's limited interpretation of a statutory exemption from the packaging requirements was neither arbitrary nor capricious, thus the seized pharmaceutical constituted an unapproved new drug barred from importation.

Appellate Information

  • Decided 05/10/2007
  • Published 05/10/2007

Judges

  • ROVNER, Circuit Judge., Before ROVNER, EVANS, and SYKES, Circuit Judges.

Court

  • United States Seventh Circuit

Counsel

  • For Appellees:
  • Douglas Letter, Department of Justice Civil Division, Appellate Section, Washington, DC, Donald R. Lorenzen (argued), Office of the United States Attorney, Chicago, IL, for Plaintiff-Appellee., Howard M. Hoffman (argued), Duane Morris, Chicago, IL, for Defendant-Appellant.
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