DC Circ. Says ViroPharma Can't Sue FDA Over Generics Ruling

Law360, New York (March 21, 2012, 3:41 PM EDT) -- The D.C. Circuit on Wednesday affirmed a lower court's decision that ViroPharma Inc. lacked standing to challenge a U.S. Food and Drug Administration ruling on generic drugs that allegedly set a precedent affecting the pharmaceutical company's business.

ViroPharma, which has an exclusive license to make Eli Lilly & Co.'s gastrointestinal antibiotic Vancocin, sued the FDA in 2010 after the agency said in a case involving diabetes drug acarbose that drugmakers can sometimes rely on lab studies, rather than human experiments, to show generics are equivalent to...
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