Drugmaker Takes FDA Generics Rule Fight To DC Circ.

Law360, New York (October 7, 2011, 8:03 PM EDT) -- Biotechnology company ViroPharma Inc. argued in a brief to the D.C. Circuit on Thursday that it has standing to sue the U.S. Food and Drug Administration over changes to generic-drug testing guidelines since they affect when potential competitors can enter the market.

ViroPharma, which has an exclusive license to make Eli Lilly & Co.'s gastrointestinal antibiotic Vancocin, sued the FDA in September 2010. The company claims the FDA illegally changed its rules in 2008 when it allowed generics makers to use laboratory tests, instead of human...
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